VersaTap, VersaLat, DueLock, VersaTi, MiniTi

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 6, 2021 Ortho-Design (Pty) Ltd % Daniel Johnson Senior Design Engineer JALEX Medical 27865 Clemens Rd. Suite 3 Westlake, Ohio 44145 Re: K212381 Trade/Device Name: VersaTapTM Suture Anchor, VersaLat™ Suture Anchor, DueLock™ Suture Anchor, VersaTiTM Suture Anchor, MiniTiTM Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 23, 2021 Received: August 2, 2021 Dear Daniel Johnson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212381 #### Device Name VersaTap™ Suture Anchor VersaTi™ Suture Anchor MiniTi™ Suture Anchor VersaLat™ Suture Anchor DueLock™ Suture Anchor Indications for Use (Describe) The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis The DueLock™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The DueLock™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator Cuff Repair, Bankart Repair, Capsular Shift and Capsulolabral Reconstruction, Subscapularis Tendon Tears Elbow: Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Metatarsal Tendon Repair. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. Hip: Acetabular labral repair. The VersaTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair, Joint capsule closure Wrist: Scapholunate ligament reconstruction Hip: Capsular Repair, acetabular labral repair Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ The MiniTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MiniTTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixsue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Elbow: Ulnar/Medial Collateral Ligament Repair Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a blue circular icon with three white curved lines inside, followed by the text "ORTHO-DESIGN" in large, blue, sans-serif font. Below "ORTHO-DESIGN" is the text "ORTHOPAEDIC INNOVATION" in a smaller, lighter font. # 510(k) Summary The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary: | Submitter Information: | Ortho-Design (Pty) Ltd<br>472 Botterklapper Street<br>Die Wilgers, Pretoria, 0184<br>South Africa | |------------------------|---------------------------------------------------------------------------------------------------| | Date: | 01/12/2021 | | Contact Person: | Dian Peach, Managing Director | | Contact Person: | Dian Peach, Managing Director | | Telephone: | (+27)128071902 | | Email: | dianpeach@ortho-design.co.za | #### DEVICE A | Device Trade Name: | VersaTap™ Suture Anchor | |---------------------------|--------------------------------------------------------------------------------------------------------| | Regulation Description: | Smooth or threaded metallic bone fixation fastener | | Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>fastener | | Regulation Number: | 21 CFR 888.3040 | | Device Classification: | Class II | | Product Code: | MBI | | Primary Predicate Device: | Parcus Twist PEEK Suture Anchor (K120942) | | Secondary Predicates: | Arthrex FT Suture Anchor (K061665)<br>Arthrex 6.5mm x 14.7mm PEEK Corkscrew FT Suture Anchor (K173788) | K063453, K130274, K070758 # Device description: Reference Devices: The VersaTap™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. This anchor is ingeniously designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects. # Indications for Use: The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ortho-Design Orthopaedic Innovation. The logo consists of a circular icon on the left and the company name on the right. The icon is a blue circle with three white lines that curve around the circle. The company name is written in blue, with "ORTHO-DESIGN" on the top line and "ORTHOPAEDIC INNOVATION" on the bottom line. - Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus - . Elbow: Tennis elbow repair - . Knee: Medial and lateral collateral ligament repair. - . Wrist: Scapholunate ligament reconstruction ## Predicate device comparison: | Primary Predicate Device Manufacturer: | Parcus Medical, LLC<br>6423 Parkland Drive<br>Sarasota, FL USA 34243 | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Relationship to the device: | Similar intended use, materials, design features, dimensions, and<br>function as the VersaTap™ Suture Anchor | | Technological Differences: | Proposed modifications consist of a smaller diameter, shorter length,<br>additional material (self-tapping titanium tip), and minor dimensional<br>changes. | | Regulatory Status: | FDA Cleared - K120942 | | Clinical Characteristics: | Suture Anchors are intended to be used for soft tissue fixation during general orthopedic surgery. | | Disclosure of performance and safety deviation: | None | |-------------------------------------------------|------| |-------------------------------------------------|------| **Technical Equivalence:** | Similar design: | Yes, except for the tip of the VersaTap being made of titanium | |-------------------------------------------------------------------------|----------------------------------------------------------------| | Similar deployment methods: | Yes | | Similar principles of operation and critical performance requirements: | Yes | | Disclosure of performance and safety deviation: | No characteristics | | Similar materials or substances in contact with the same human tissues: | Yes | | Disclosure of performance and safety deviation: | Yes | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Ortho-Design. The logo consists of a blue circular icon with three curved lines inside, followed by the text "ORTHO-DESIGN" in a larger, bolder blue font. Below the company name, the words "ORTHOPAEDIC INNOVATION" are written in a smaller, lighter font. # Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing including static pull-out, insertion torque, fatigue, and corrosion testing as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions. This testing was done on the subject device and the primary predicate device. The comparison shows that the subject device has similar or improved pull out force compared to the primary predicate. # Biocompatibility: The reference devices selected for biocompatibility evaluation (510(k) numbers) are manufactured by Elite Surgical Supplies, at the same manufacturing facility producing the subject devices, using the same manufacturing processes, chemicals, materials, and cleaning processes as the subject devices. An OEM manufacturing contract is in place between Elite Surgical Supplies and Ortho-Design, stating that all manufacturing done for Ortho-Design, by Elite Surgical Supplies, is done according to the processes defined by ISO 9001. All materials, processes, and cleaning agents used for the subject device have previously been cleared by the FDA for the reference device. ## Sterility: After reviewing the results of the IQ, OQ and PQ results, it can be concluded that the Overkill Method was successfully conducted in order to achieve a SAL of 10-6 based on the parameters and tolerances identified during the validation study. ## Shelf-Life: The VersaTap™ Suture Anchor has a shelf-life of 3 years, which has been validated with accelerated aging techniques listed above in 016 Sterilization and Shelf-Life Table 2. Real-time aging is being conducted and the design history file will be updated with this information when completed. The implant components are manufactured from PEEK OPTIMA conforming to ASTM F2026 and Titanium Alloy conforming to ASTM F136. All materials have been historically used in implant devices and have demonstrated not to be mechanically affected by aging within the 3 year shelf life , so no additional aging testing is required for the implants. # Packaging: The VersaTap™ Suture Anchor will be boxed individually in EtO sterilized double peel pouches to allow for easy transfer into the sterile operative field. Both the inner and outer pouch is a 60g/m² medical plastic film and paper peel pouch. Each package includes external package labeling, an instruction leaflet, and individual patient labels. Instruments are provided non-sterilization trays separately from the implants. # Endotoxin/pyrogenicity: The device has been tested to be non-pyrogenic. # Conclusion: From the non-clinical testing results and summaries, it is clear that the VersaTap™ Suture Anchor demonstrates substantial equivalence and adheres to minimum requirements set out in the guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions laid out by the FDA. This was demonstrated by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a blue circular icon with three curved white lines inside, followed by the text "ORTHO-DESIGN" in a larger, bolder blue font. Below "ORTHO-DESIGN" is the text "ORTHOPAEDIC INNOVATION" in a smaller, thinner font. ## DEVICE B | Device Trade Name: | VersaLat™ Suture Anchor | |---------------------------|-----------------------------------------------------------------------------------------| | Regulation Description: | Smooth or threaded metallic bone fixation fastener | | Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulation Number: | 21 CFR 888.3040 | | Device Classification: | Class II | | Product Code: | MBI | | Primary Predicate Device: | DePuy Mitek Healix Advance Knotless BR Anchor (K130917) | | Secondary Predicates: | Arthrex Swivelock (K190728)<br>Arthrex Swivelock SP 5.5 x 24.5mm - AR-2323SLM (K203495) | | Reference devices: | K130274, K070758 | #### Device description: The VersaLat™ Suture Anchor is an innovative knotless-/suture anchor inspired by a top orthopedic shoulder surgeon. This PEEK screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differs this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments # Indications for Use: The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - Shoulder: Rotator Cuff Repair, Biceps Tenodesis - Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis ### Predicate device comparison: | Primary Predicate Device Manufacturer: | DePuy<br>325 Paramount Dr<br>Raynham, MA 02767 | |----------------------------------------|---------------------------------------------------------------------------------------------------| | Relationship to the device: | Similar intended use, design features, dimensions, and function as<br>the VersaLat™ Suture Anchor | | Technological Differences | Similar design, indications for use, and engineering principles with | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a blue abstract symbol on the left, followed by the text "ORTHO-DESIGN" in a larger, bolder blue font. Below "ORTHO-DESIGN" is the text "ORTHOPAEDIC INNOVATION" in a smaller, lighter font. addition of small titanium tip and sutures loop, instead of eyelid, for insertion of external sutures. | Regulatory Status: | |--------------------| |--------------------| FDA cleared - K130917 # Clinical Characteristics: Suture Anchors are intended to be used for soft tissue fixation during general orthopedic surgery. | Disclosure of performance and safety deviation: | None | |-------------------------------------------------|------| |-------------------------------------------------|------| **Technical Equivalence:** | Similar design: | Yes | |------------------------------------------------------------------------|-----| | Similar deployment methods: | Yes | | Similar principles of operation and critical performance requirements: | Yes | | Disclosure of performance and safety deviation: | No characteristics | |-------------------------------------------------------------------------|--------------------| | Similar materials or substances in contact with the same human tissues: | Yes | | Disclosure of performance and safety deviation: | Yes | # Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing including static pull-out, insertion torque, fatigue, and corrosion testing as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions. This testing was done on the subject device and compared to the data found in literature (Cyclic Biomechanical Testing of Biocomposite Lateral Row Knotless Anchors in a Human Cadaveric Model, A. Barberl et al, 2013, p3, Table 1). The comparison shows that the subject device has similar or improved pull out force compared to the primary predicate. # Biocompatibility: The reference devices selected for biocompatibility evaluation (510(k) numbers) are manufactured by Elite Surgical Supplies, at the same manufacturing facility producing the subject devices, using the same manufacturing processes, chemicals, materials, and cleaning processes as the subject devices. An OEM manufacturing contract is in place between Elite Surgical Supplies and Ortho-Design, stating that all manufacturing done for Ortho-Design, by Elite Surgical Supplies, is done according to the processes defined by ISO 9001. All materials, processes, and cleaning agents used for the subject device have previously been cleared by the FDA for the reference device. # Sterility: After reviewing the results of the IQ, OQ and PQ results, it can be concluded that the Overkill Method was successfully conducted in order to achieve a SAL of 10-6 based on the parameters and tolerances identified during the validation study. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "Ortho-Design." The logo consists of a circular graphic to the left of the text. The graphic is a blue circle with three white curved lines inside. Below the main text is the phrase "Orthopaedic Innovation" in a smaller font. # Shelf-Life: The VersaLat™ Suture Anchor has a shelf-life of 3 years, which has been validated with accelerated aging techniques listed above in 016 Sterilization and Shelf-Life Table 2. Real-time aging is being conducted and the design history file will be updated with this information when completed. The implant components are manufactured from PEEK OPTIMA conforming to ASTM F2026 and Titanium Alloy conforming to ASTM F136. All materials have been historically used in implant devices and have demonstrated not to be mechanically affected by aging within the 3 year shelf life, so no additional aging testing is required for the implants. # Packaging: The VersaLat™ Suture Anchor will be boxed individually in EtO sterilized double peel pouches to allow for easy transfer into the sterile operative field. Both the inner and outer pouch is a 60g/m² medical plastic film and paper peel pouch. Each package includes external package labeling, an individual patient labels. Instruments are provided non-sterilization trays separately from the implants. ## Endotoxin/pyrogenicity: The device has been tested to be non-pyrogenic. ## Conclusion: From the non-clinical testing results and summaries, it is clear that the VersaLat™ Suture Anchor demonstrates substantial equivalence and adheres to minimum requirements set out in the guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions laid out by the FDA. This was demonstrated by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests. # DEVICE C | Device Trade Name: | DueLock™ Suture Anchor | |---------------------------|---------------------------------------------------------------------| | Regulation Description: | Smooth or threaded metallic bone fixation fastener | | Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulation Number: | 21 CFR 888.3040 | | Device Classification: | Class II | | Product Code: | MBI | | Primary Predicate Device: | Arthrex PEEK Mini Pushlock Anchor (K201786) | | Secondary Predicates: | Arthrex PEEK Pushlock (K101679) | | | Parcus Knotless PEEK CF Push-in 3.5 x 10mm - 10313 (K193295) | | | Smith and Nephew 2.9mm BioRaptor (K121018) | Reference Devices: K130274, K070758 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Ortho-Design. The logo consists of a blue circular icon with three white curved lines inside, followed by the text "ORTHO-DESIGN" in blue, and "ORTHOPAEDIC INNOVATION" in a smaller, thinner font below. The logo is clean and modern, suggesting innovation in the field of orthopedics. ## Device description: The DueLock™ Suture Anchor is a flexible anchor that combines the functional push-in anchors into one multi-purpose suture anchor can be used as a knotless suture anchor as well as a push-in, preloaded suture anchor used in both small and large-joint repairs. ## Indications for Use: The DueLock™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The DueLock™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Capsular Shift and Capsulolabral Reconstruction, Subscapularis Tendon Tears - . Elbow: Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair - Foot/Ankle: Lateral Stabilization, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Metatarsal Tendon Repair. - Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. - Hip: Acetabular labral repair. #### Predicate device comparison: | Primary Predicate Device Manufacturer: | Arthrex Inc.Orbison Street<br>1370 Creekside Boulevard<br>Naples, Florida 34108-1945 | |----------------------------------------|------------------------------------------------------------------------------------------------------------| | Relationship to the device: | Similar intended use, materials, design features, dimensions, and<br>function as the DueLock Suture Anchor | | Technological Differences: | Proposed modifications consist of a shorter length and minor<br>dimensional changes. | | Regulatory Status: | FDA Cleared - K201786 | #### Clinical Characteristics: Suture Anchors are intended to be used for soft tissue fixation during general orthopedic surgery. Disclosure of performance and safety deviation: None {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Ortho-Design. The logo consists of a blue circular icon with three white curved lines inside, followed by the text "ORTHO-DESIGN" in large, blue, serif font. Below the company name, the text "ORTHOPAEDIC INNOVATION" is written in a smaller, thinner, sans-serif font. ## Technical Equivalence: | Similar design: | Yes | |-------------------------------------------------------------------------|--------------------| | Similar deployment methods: | Yes | | Similar principles of operation and critical performance requirements: | Yes | | Disclosure of performance and safety deviation: | No characteristics | | Similar materials or substances in contact with the same human tissues: | Yes | | Disclosure of performance and safety deviation: | Yes | # Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing including static pull-out, insertion torque, fatigue and corrosion testing as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions. This testing was done on the subject device and compared to the data found in literature (Pull-out Strength of Various Knotless Hip Suture Anchors (arthrex.com)). The comparison shows that the subject device has similar or improved pull out force compared to the primary predicate. #### Biocompatibility: The reference devices selected for biocompatibility evaluation (510(k) numbers) are manufactured by Elite Surgical Supplies, at the same manufacturing facility producing the same manufacturing processes, chemicals, materials, and cleaning processes as the subject devices. An OEM manufacturing contract is in place between Elite Surgical Supplies and Ortho-Design, stating that all manufacturing done for Ortho-Design, by Elite Surgical Supplies, is done according to the processes defined by ISO 13485 and ISO 9001. All materials, processes, and cleaning agents used for the subject device have previously been cleared by the FDA for the reference device. #### Sterility: After reviewing the results of the IQ, OQ and PQ results, it can be concluded that the Overkill Method was successfully conducted in order to achieve a SAL of 10-6 based on the parameters and tolerances identified during the validation study. #### Shelf-Life: The DueLock™ Suture Anchor has a shelf-life of 3 years, which has been validated with accelerated aging techniques listed above in 016 Sterilization and Shelf-Life Table 2. Real-time aging is being conducted and the design history file will be updated with this information when completed. The implant components are manufactured from PEEK OPTIMA conforming to ASTM F2026 and Titanium Alloy conforming to ASTM F136. All materials have been historically used in implant devices and have demonstrated not to be mechanically affected by aging within the 3 year shelf life, so no additional aging testing is required for the implants. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a stylized blue symbol on the left, resembling three interconnected loops. To the right of the symbol, the words "ORTHO-DESIGN" are written in a bold, dark blue font. Below "ORTHO-DESIGN", the words "ORTHOPAEDIC INNOVATION" are written in a smaller, lighter blue font. ## Packaging: The DueLock™ Suture Anchor will be boxed individually in EtO sterilized double peel pouches to allow for easy transfer into the sterile operative field. Both the inner and outer pouch is a 60g/m² medical plastic film and paper peel pouch. Each package includes external package labeling, an instruction leaflet, and individual patient labels. Instruments are provided non-sterilization trays separately from the implants. ## Endotoxin/pyrogenicity: The device has been tested to be non-pyrogenic. ## Conclusion: From the non-clinical testing results and summaries, it is clear that the DueLock™ Suture Anchor demonstrates substantial equivalence and adheres to minimum requirements set out in the guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions laid out by the FDA. This was demonstrated by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests. #### DEVICE D | Device Trade Name: | VersaTi™ Suture Anchor | |---------------------------|---------------------------------------------------------------------------------------------| | Regulation Description: | Smooth or threaded metallic bone fixation fastener | | Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulation Number: | 21 CFR 888.3040 | | Device Classification: | Class II | | Product Code: | MBI | | Primary Predicate Device: | Arthrex corkscrew™ FT II Anchor (K050358) =<br>Parcus V-Lox 4.5 x 13.9mm – 10353T (K201083) | | Reference Devices: | K063456, K130274 | #### Device description: The VersaTi™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. The anchor is designed for ultimate mechanical properties (pull-out strength, etc.) and ease of use. VersaTi™ Suture Anchor is recommended for use in small and large-joint repairs without the need for tapping or drilling. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Ortho-Design Orthopaedic Innovation. The logo consists of a blue circular icon with three curved white lines inside. To the right of the icon is the text "ORTHO-DESIGN" in a larger, bolder blue font, with the words "ORTHOPAEDIC INNOVATION" underneath in a smaller, thinner font. ## Indications for Use: The VersaTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - . Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair - . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus - Elbow: Tennis elbow repair - Knee: Medial and lateral collateral ligament repair, Joint capsule closure - Wrist: Scapholunate ligament reconstruction - Hip: Capsular Repair, acetabular labral repair #### Predicate device comparison: | Primary Predicate Device Manufacturer: | Arthrex Inc.Orbison Street<br>1370 Creekside Boulevard<br>Naples, Florida 34108-1945 | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Relationship to the device: | Similar intended use, materials, design features, dimensions, and<br>function as the VersaTi Suture Anchor | | Technological Difference | The thread of the subject device is designed for optimal pull-out<br>strength and mechanical stability. Thread design for cancellous and<br>cortical fixation. | | Regulatory Status: | FDA cleared - K050358 | #### Clinical Characteristics: Suture Anchors are intended to be used for soft tissue fixation during general orthopedic surgery. | Disclosure of performance and safety deviation: | None | |-------------------------------------------------|------| |-------------------------------------------------|------| #### Technical Equivalence: Similar design: Yes - Similar deployment methods: Yes {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a blue circular symbol on the left, followed by the words "ORTHO-DESIGN" in a larger, bolder blue font. Below "ORTHO-DESIGN" is the text "ORTHOPAEDIC INNOVATION" in a smaller, thinner blue font. The overall design is clean and professional, conveying a sense of innovation and expertise in the field of orthopaedics. Similar principles of operation and critical performance requirements: Yes | Disclosure of performance and safety deviation: | No characteristics | |-------------------------------------------------------------------------|--------------------| | Similar materials or substances in contact with the same human tissues: | Yes | | Disclosure of performance and safety deviation: | Yes | # Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing including static pull-out, insertion torque, fatigue and corrosion testing as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions. This testing was done on the subject device and compared to the data found in literature (Suture Anchor Materials, Eyelets, and Designs: Update 2008, A. Barber et al, 2008, p6, Table 2). The comparison shows that the subject device has similar or improved pull out force compared to the primary predicate. ## Biocompatibility: The reference devices selected for biocompatibility evaluation (510(k) numbers) are manufactured by Elite Surgical Supplies, at the same manufacturing facility producing the subject devices, using the same manufacturing processes, chemicals, materials, and cleaning processes as the subject devices. An OEM manufacturing contract is in place between Elite Surgical Supplies and Ortho-Design, stating that all manufacturing done for Ortho-Design, by Elite Surgical Supplies, is done according to the processes defined by ISO 9001. All materials, processes, and cleaning agents used for the subject device have previously been cleared by the FDA for the reference device. # Sterility: After reviewing the results of the IQ, OQ and PQ results, it can be concluded that the Overkill Method was successfully conducted in order to achieve a SAL of 10-6 based on the parameters and tolerances identified during the validation study. #### Shelf-Life: The VersaTi™ Suture Anchor has a shelf-life of 3 years, which has been validated with accelerated aging techniques listed above in 016_Sterilization and Shelf-Life Table 2. Real-time aging is being conducted and the design history file will be updated with this information when completed. The implant components are manufactured from PEEK OPTIMA conforming to ASTM F2026 and Titanium Alloy conforming to ASTM F136. All materials have been historically used in implant devices and have proven not to be mechanically affected by aging within the 3 years shelf life, so no additional aging testing is required for the implants. #### Packaging: The VersaTi™ Suture Anchor will be boxed individually in EtO sterilized double peel pouches to allow for easy transfer into the sterile operative field. Both the inner and outer pouch is a 60g/m² medical plastic film and paper peel pouch. Each package includes external package labeling, an instruction leaflet, and individual patient labels. Instruments are provided non-sterile in steam sterilization trays separately from the implants. #### Endotoxin/pyrogenicity: The device has been tested to be non-pyrogenic. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image is a logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a blue circular icon with three white curved lines inside, followed by the words "ORTHO-DESIGN" in large, blue, serif font. Below that, the words "ORTHOPAEDIC INNOVATION" are written in a smaller, thinner, sans-serif font. Conclusion: From the non-clinical testing results and summaries, it is clear that the VersaTi™ Suture Anchor demonstrates substantial equivalence and adheres to minimum requirements set out in the guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions laid out by the FDA. This was demonstrated by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests. ## DEVICE E | Device Trade Name: | MiniTi™ Suture Anchor | |---------------------------|---------------------------------------------------------------------------------------------------------------------------| | Regulation Description: | Smooth or threaded metallic bone fixation fastener | | Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulation Number: | 21 CFR 888.3040 | | Device Classification: | Class II | | Product Code: | MBI | | Primary Predicate Device: | De Puy Mitek MiniLok QuickAnchor (K071257) | | Secondary Predicates: | Parcus Medical MiTi (K111000)<br>Arthrex 2.2mm Micro Corkscrew FT Suture Anchor (K173788)<br>Rejoin Medical 2mm Ti Anchor | | Reference Devices: | K063453, K200523, K070758 | # Device description: The MiniT™ Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength. # Indications for Use: The MiniT™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MiniTT™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - Elbow: Ulnar/Medial Collateral Ligament Repair - . Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Achilles Tendon Repair, Midfoot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. - . Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for "ORTHO-DESIGN ORTHOPAEDIC INNOVATION". The logo consists of a blue circular icon with three white curved lines inside, followed by the text "ORTHO-DESIGN" in a larger, bolder blue font. Below the text, "ORTHOPAEDIC INNOVATION" is written in a smaller, thinner font. ### Predicate device comparison: | Primary Predicate Device Manufacturer: | DePuy<br>325 Paramount Dr<br>Raynham, MA 02767 | |----------------------------------------|---------------------------------------------------------------------------------------------------------| | Relationship to the device: | Similar intended use, materials, design features, dimensions, and function as the MiniTi™ Suture Anchor | | Technological Differences | Minor dimensional changes | | Regulatory Status: | FDA cleared – K071257 | **Clinical Characteristics:** Suture Anchors are intended to be used for soft tissue fixation during general orthopedic surgery. | Disclosure of performance and safety deviation: | None | |-------------------------------------------------|------| |-------------------------------------------------|------| **Technical Equivalence:** | Similar design: | Yes | |-------------------------------------------------------------------------|--------------------| | Similar deployment methods: | Yes | | Similar principles of operation and critical performance requirements: | Yes | | Disclosure of performance and safety deviation: | No characteristics | | Similar materials or substances in contact with the same human tissues: | Yes | | Disclosure of performance and safety deviation: | Yes | # Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing including static pull-out, insertion torque, fatigue, and corrosion testing as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions. This testing was done on the subject device and compared to the data found in literature (https://www.smith-nephew.com/global/assets/odf/products/surgical/extremities hand%20wrist bro f.pdf). The comparison shows that the subject device has similar or improved pull out force compared to the primary predicate. {17}------------------------------------------------ Image /page/17/Picture/0 description: The image shows the logo for "Ortho-Design Orthopaedic Innovation". The logo consists of a blue circular icon with three curved white lines inside, followed by the text "ORTHO-DESIGN" in a larger, bolder blue font. Below "ORTHO-DESIGN" is the text "ORTHOPAEDIC INNOVATION" in a smaller, lighter font. # Biocompatibility: The reference devices selected for biocompatibility evaluation (510(k) numbers) are manufactured by Elite Surgical Supplies, at the same manufacturing the subject devices, using the same manufacturing processes, chemicals, materials, and cleaning processes as the subject devices. An OEM manufacturing contract is in place between Elite Surgical Supplies and Ortho-Design, stating that all manufacturing done for Ortho-Design, by Elite Surgical Supplies, is done according to the processes defined by ISO 9001. All materials, processes, and cleaning agents used for the subject device have previously been cleared by the FDA for the reference device. # Sterility: After reviewing the results of the IQ, OQ and PQ results, it can be concluded that the Overkill Method was successfully conducted in order to achieve a SAL of 10-6 based on the parameters and tolerances identified during the validation study. # Shelf-Life: The MiniTi™ Suture Anchor has a shelf-life of 3 years, which has been validated with accelerated aging techniques listed above in 016_Sterilization and Shelf-Life Table 2. Real-time aging is being conducted and the design history file will be updated with this information when completed. The implant components are manufactured from PEEK OPTIMA conforming to ASTM F2026 and Titanium Alloy conforming to ASTM F136. All materials have been historically used in implant devices and have proven not to be mechanically affected by aging within the 3 years of shelf life, so no additional aging testing is required for the implants. # Packaging: The MiniTT™ Suture Anchor will be boxed individually in EtO sterilized double peel pouches to allow for easy transfer into the sterile operative field. Both the inner and outer pouch is a 60g/m² medical plastic film and paper peel pouch. Each package includes external package labeling, an instruction leaflet, and individual patient labels. Instruments are provided non-sterile in steam sterilization trays separately from the implants. # Endotoxin/pyrogenicity: The device has been tested to be non-pyrogenic. # Conclusion: From the non-clinical testing results and summaries, it is clear that the MiniTi demonstrates substantial equivalence and adheres to minimum requirements set out in the guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions laid out by the FDA. This was demonstrated by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests.