Stativ® Knotted UHMWPE Suture Anchor

{0}------------------------------------------------ March 22, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Healthium Medtech Limited Pankaj Dawar Deputy General Manager Regulatory Affairs 472-D. 13th Cross, 4th Phase, Peenya Industrial Area Bangalore. Karnataka 560058 India Re: K223889 Trade/Device Name: Stativ® Knotted UHMWPE 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: December 23, 2022 Received: December 27, 2022 Dear Pankaj Dawar: 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. 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 {1}------------------------------------------------ 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. # Sara S. Thompson -S For Laurence D. Coyne. Ph.D. Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223889 Device Name STATIV® Knotted UHMWPE Suture Anchor ### Indications for Use (Describe) The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures: 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. 2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction. 3. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. 4. Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). 5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction. 6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is in large, bold, black letters, with the "O" in "Sironix" being a red circle. Below "Sironix" is the phrase "Arthroscopy Solutions" in smaller, black letters. Image /page/3/Picture/2 description: The image contains the text "K223889" at the top left. To the right of the text is a logo with an orange circle overlapping a blue circle with a white cross in the middle. Below the text and logo is the word "Healthium" in a blue, sans-serif font. # 1. 510(k) Summary #### 1.1. Submitter Information: | Application Correspondent: | PANKAJ DAWAR<br>Healthium Medtech Limited<br>472-D, 13th Cross, 4th Phase,<br>Peenya Industrial Area,<br>Bangalore, Karnataka, 560058, INDIA. | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Phone: | +91-9886529934 | | E-mail: | pankaj.d@healthiummedtech.com | | Specification Developer: | Healthium Medtech Limited<br>472-D, 13th Cross, 4th Phase,<br>Peenya Industrial Area,<br>Bangalore, Karnataka, 560058, INDIA. | | Contact Person: | PANKAJ DAWAR | | Phone: | + 91-80-41868000 | | E-mail: | pankaj.d@healthiummedtech.com | | Date Prepared: | 20-03-2023 | #### 1.2. Device Identification: | Device Trade Name: | STATIV® Knotted UHMWPE Suture Anchor | |----------------------|----------------------------------------------------| | Device Common Name: | Non-Absorbable Suture Anchor | | Classification Name: | Smooth or threaded metallic bone fixation fastener | | Device Class: | Class II | | Regulation Number: | 21 CFR 888.3040 | | Product Code: | MBI | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller font. Image /page/4/Picture/2 description: The image contains the text "K223889" in a bold, sans-serif font. Below the text is the word "Healthium" in a larger, bold, sans-serif font. To the right of the text is a logo consisting of an orange circle overlapping a blue circle, with a white cross shape where they intersect. #### 1.3. Predicate Devices: | Device Name | 510(k) Number | |------------------------------------------|---------------| | Arthrex FiberTak Suture Anchor (Primary) | K203268 | | Fixone All Suture Anchor (Secondary) | K192709 | #### Device Description 1.4. The STATIV® Knotted UHMWPE Suture Anchor is a fixation device intended to provide secure fixation of soft tissue to bone and is available in self-tap/self-punching variant also. It consists of a soft Suture Anchor with attached non-absorbable suture(s) to an inserter with handle. The Anchor are available in various sizes, preloaded with suture, tape or suture-tape combinations. This device is provided sterile, for single use only. # Materials Specifications - 1. Anchor : - > Loop: Non-absorbable, UHMWPE USP #3, USP #7 - A Suture : Non-absorbable, UHMWPE USP #2 - A Tape : Non-absorbable UHMWPE 1.5mm Round-Flat-Round - A Additive: Polycaprolactone (Average Mn 80,000) - 2. Dispenser : Stainless Steel (SS 300 Series) - 3. Handle : ABS (Acrylonitrile Butadiene Styrene) - Ring : Silicone Rubber Ring 4. #### Intended Use & Indications for Use 1.5. # Intended Use STATIV® Knotted UHMWPE Suture Anchor with the sutures/tapes are Intended for soft tissue fixation to the bone. These sutures/tapes may be incorporated, as components, into surgeries where constructs including those with allograft or auto graft tissues are used for repair. # Indications for Use The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures: - 1. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. - 2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Midfoot reconstruction. | Healthium Medtech Limited | | |----------------------------------------------------------------------------------------------------|-------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India | Page 2 of 7 | | www.healthiummedtech.com CIN : U03311KA1992PLC013831 | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is written in a bold, sans-serif font, with the "O" in "Sironix" replaced by a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. Image /page/5/Picture/2 description: The image contains the text "K223889" at the top, followed by the word "Healthium" in a stylized font. To the right of the text is a logo consisting of a blue circle intersected by a white cross, with an orange circle partially overlapping the blue one. The logo is simple and modern, complementing the text. - 3. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. - 4. Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). - 5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction. - 6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair. #### 1.6. Comparison of Technological Characteristics The fundamental scientific technology, materials of construction and mechanism of operation are similar between the subject device STATIV® Knotted UHMWPE Suture Anchor and the predicate device. Table 2 summarizes the comparison of technological characteristics between the subject and predicate device. | S. No | Parameters | Arthrex FiberTak Suture<br>Anchor (K203268) | STATIV® Knotted<br>UHMWPE Suture Anchor<br>(Subject device) | Comments | |-------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | 1. | Manufacturer | Arthrex Inc. | Healthium Medtech Limited | - | | 2. | Product Code | MBI | MBI | Similar | | 3. | Regulation<br>Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Similar | | 4. | Classification | Class II | Class II | Similar | | 5. | Intended Use | The Arthrex FiberTak Suture<br>Anchor is intended for<br>fixation of suture (soft tissue)<br>to bone in the shoulder,<br>foot/ankle, knee, hand/wrist,<br>elbow, and hip in the<br>following procedures:<br>Elbow: Biceps Tendon<br>Reattachment, Ulnar or<br>Radial Collateral Ligament<br>Reconstruction<br>Shoulder: Rotator Cuff<br>Repair, Bankart Repair, SLAP<br>Lesion Repair, Biceps<br>Tenodesis, Acromio-<br>Clavicular Separation Repair, | The STATIV® Knotted<br>UHMWPE Suture Anchor is<br>indicated for the fixation, by<br>use of sutures, of soft tissue to<br>bone in the following surgical<br>procedures:<br>1. Shoulder: Rotator Cuff<br>Repair, Bankart Repair,<br>SLAP Lesion Repair,<br>Biceps Tenodesis,<br>Acromio-Clavicular<br>Separation Repair, Deltoid<br>Repair, Capsular Shift or<br>Capsulolabral<br>Reconstruction.<br>2. Foot/Ankle: Lateral<br>Stabilization, Medial | Similar | # Table 2: Substantial Equivalence Table | Healthium Medtech Limited | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India<br>www.healthiummedtech.com CIN : U03311KA1992PLC013831 | Page 3 of 7 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Sironix. The logo is black, except for the "O" in Sironix, which is red. Below the company name is the text "Arthroscopy Solutions". Image /page/6/Picture/2 description: The image contains the text "K223889" in a bold, sans-serif font at the top. Below the text is the word "Healthium" in a stylized font, with the "H" being larger than the other letters. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the center where they overlap. | S.<br>No | Parameters | Arthrex FiberTak Suture<br>Anchor (K203268) | STATIV® Knotted<br>UHMWPE Suture Anchor<br>(Subject device) | Comments | |----------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | | Deltoid Repair, Capsular Shift<br>or Capsulolabral<br>Reconstruction<br><b>Hand/Wrist:</b> Scapholunate<br>Ligament Reconstruction,<br>Repair/Reconstruction of<br>collateral ligaments, Repair of<br>Flexor and Extensor Tendons<br>at the PIP, DIP and MCP<br>joints for all digits, digital<br>tendon transfers, Carpal<br>Ligament Reconstruction and<br>Carpometacarpal joint<br>arthroplasty (basal thumb<br>joint arthroplasty)<br><b>Foot/Ankle:</b> Lateral<br>Stabilization, Medial<br>Stabilization, Achilles Tendon<br>Repair, Metatarsal Ligament<br>Repair, Hallux Valgus<br>reconstruction, digital tendon<br>transfers, Mid-foot<br>reconstruction<br><b>Knee:</b> Medial Collateral<br>Ligament Repair, Lateral<br>Collateral Ligament Repair,<br>Patellar Tendon Repair,<br>Posterior Oblique Ligament<br>Repair, Iliotibial Band<br>Tenodesis, Joint Capsule<br>Closure<br><b>Hip:</b> Capsular repair,<br>Acetabular labral repair,<br>Gluteal Tendon Repair. | Stabilization, Achilles<br>Tendon Repair, Metatarsal<br>Ligament Repair, Hallux<br>Valgus reconstruction,<br>digital tendon transfers,<br>Mid-foot reconstruction.<br>3. Knee: Medial Collateral<br>Ligament Repair, Lateral<br>Collateral Ligament<br>Repair, Patellar Tendon<br>Repair, Posterior Oblique<br>Ligament Repair, Iliotibial<br>Band Tenodesis, Joint<br>Capsule Closure.<br>4. Hand/Wrist: Scapholunate<br>Ligament Reconstruction,<br>Repair/Reconstruction of<br>collateral ligaments, Repair<br>of Flexor and Extensor<br>Tendons at the PIP, DIP<br>and MCP joints for all<br>digits, digital tendon<br>transfers, Carpal Ligament<br>Reconstruction and<br>Carpometacarpal joint<br>arthroplasty (basal thumb<br>joint arthroplasty).<br>5. Elbow: Biceps tendon<br>reattachment, Ulnar or<br>Radial collateral ligament<br>reconstruction.<br>6. Hip: Acetabular labral<br>repair, Capsular repair,<br>Gluteal Tendon Repair. | | | 6. | Anchor Loop<br>Material | Hollow braid of polyester | UHMWPE | SE Analysis 1 | | 7. | Suture<br>&<br>Tape Material | UHWMPE or a polyblend of<br>UHMWPE and polyester | Suture- UHMWPE USP #2,<br>Tape- UHMWPE 1.5mm flat | Similar | | 8. | Design | Arthrex Suture Anchor are<br>designed to repair soft tissue<br>to bone through a variety of<br>innovative anchor styles,<br>materials, and suture<br>configurations. As the next | STATIV® Knotted<br>UHMWPE Suture Anchor<br>constructed of strong Ultra<br>High Molecular Weight<br>Polyethylene (UHMWPE)<br>suture material. STATIV® | Similar | | Healthium Medtech Limited | | |------------------------------------------------------------------------------------------------------------------|--| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru - 560058, India Page 4 of 7 | | | www.healthiummedtech.com CIN : U03311KA1992PLC013831 | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is in bold, with the "O" in "SIRONIX" being a red circle. Underneath "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, less bold font. The logo is simple and professional. Image /page/7/Picture/2 description: The image contains the text "K223889" in a bold, sans-serif font. Below the text is the word "Healthium" in a stylized, blue font. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the center where they intersect. | S.<br>No | Parameters | Arthrex FiberTak Suture<br>Anchor (K203268) | STATIV® Knotted<br>UHMWPE Suture Anchor<br>(Subject device) | Comments | |----------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | | evolution of knotless rotator<br>cuff repair, the FiberTak<br>SpeedBridge technique is<br>completed with FiberTak soft<br>Anchor on the medial row and<br>FiberTape® sutures fixated<br>laterally with trusted<br>SwiveLock® Anchor. This<br>knotless repair creates a<br>quick, secure construct in as<br>few as three suture passing<br>steps. | Knotted UHMWPE Suture<br>Anchor is the Suture Anchor<br>with sutures(s)/tape(s)<br>combination. It assured<br>centralized deployment of the<br>anchor into pilot hole. Post<br>deployment, the unique tri-<br>pod bunched up pattern<br>doubles its size, which gives<br>much higher pull out strength. | | | 9. | Specifications<br>and<br>Dimensions | FiberTak Suture Anchor with #2<br>FiberWire CL (White/Blue) --<br>AR-3600<br>FiberTak Suture Anchor, double<br>loaded with two #2 FiberWire<br>CL (White/Blue, White/Black),-<br>AR-3600-2<br>FiberTak with 1.3 mm<br>SutureTape (White/Blue), - AR-<br>3602<br>FiberTak Suture Anchor, Double<br>Loaded with two 1.3 mm<br>SutureTape (White/Blue,<br>White/Black),- AR-3602-2<br>FiberTak with #2 TigerTail<br>(Blue/Black) -AR-3603<br>FiberTak Suture Anchor, Double<br>Loaded with two #2 TigerTail<br>(Blue/Black and White/Black)-<br>AR-3603-2<br>2.6 FiberTak Soft Anchor,<br>Double Loaded with two #2<br>FiberWire CL (Blue/White,<br>Black/White) -AR-3630-1<br>2.6 FiberTak Soft Anchor, Triple<br>Loaded with three #2 FiberWire<br>CL (Blue/White, Black/White,<br>White)- AR-3631-1<br>2.6 FiberTak Soft Anchor,<br>Double Loaded with two 1.3 mm | 1.5mm Single Suture<br>1.8mm Single Suture<br>1.5mm Single Tape<br>1.8mm Single Tape<br>1.8mm Double Sutures<br>1.8mm Double Tapes<br>2.5 mm Double Sutures (Self-<br>Tap)<br>2.5 mm Double Tapes (Self-Tap)<br>2.5 mm Triple Sutures (Self-Tap)<br>2.9 mm Double Sutures (Self-<br>Tap)<br>2.9 mm Double Tapes (Self-Tap)<br>2.9 mm Triple Sutures (Self-Tap) | SE Analysis 2 | | Healthium Medtech Limited | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India<br>www.healthiummedtech.com CIN : U03311KA1992PLC013831 | Page 5 of 7 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below "SIRONIX" is the text "Arthroscopy Solutions" in a smaller, sans-serif font. Image /page/8/Picture/2 description: The image contains the text "K223889" in black font at the top left. Below the text is the word "Healthium" in a blue, stylized font. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue. | S.<br>No | Parameters | Arthrex FiberTak Suture<br>Anchor (K203268) | STATIV® Knotted<br>UHMWPE Suture Anchor<br>(Subject device) | Comments | |----------|---------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | | | SutureTape (White/Blue and<br>White/Black) - AR-3632 | | | | | | 2.6 FiberTak Soft Anchor, Triple<br>Loaded with three 1.3 mm<br>SutureTape (White/Blue,<br>White/Black and White)- AR-<br>3633 | | | | 10. | Single<br>Use/Reuse | Single Use | Single Use | Similar | | 11. | Shelf Life | 5 years | 5 Years | Similar | | 12. | Sterilization | Provided in Sterile conditions<br>(EO Sterilization). | Provided in Sterile conditions<br>(EO Sterilization). | Similar | | 13. | Performance<br>Data | Cyclic pull-out test,<br>Bacterial Endotoxin | Bench Performance:<br>Pull out Strength<br>Cyclical Loading<br>Bacterial Endotoxin | Similar | | 14. | Safety Data | No Data Available | Biocompatibility:<br>Skin Sensitization,<br>Intracutaneous reactivity,<br>Material Mediated<br>Pyrogenicity,<br>Acute Systemic Toxicity,<br>In vitro cytotoxicity. | - | # SE Analysis 1: # Anchor Material: Difference in Anchor Material does not affect the safety and efficacy of subject device based on the reference comparative study. Predicate device (K203268) has an anchor loop made up of Hollow braid of polyester, whereas the subject device has an anchor made up of UHMWPE. From the literature study4 it can be inferred that the Polyester suture had lower ultimate load than all groups of sutures used in the study except the suture composed of polyester and UHMWPE (P<.05). Pure UHMWPE suture had higher ultimate failure load than sutures composed of either polyester or polyester plus UHMWPE (P<.05). Predominant failure mode was suture cutting through the meniscus for the groups except for polyester suture which failed by suture rupture. This literature study shows that UHMWPE material has better ultimate load than the material used in predicate and this change is not raising any questions on the safety and efficacy of the subject device. | Healthium Medtech Limited | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India<br>www.healthiummedtech.com CIN : U03311KA1992PLC013831 | Page 6 of 7 | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller font. Image /page/9/Picture/2 description: The image contains the alphanumeric string "K223889" in black font. Below this string is the word "Healthium" in a bold, blue font. To the right of the word "Healthium" is a logo consisting of a blue circle and an orange circle, with a white cross shape overlaying them. Reference 1: The influence of suture material on the strength of horizontal mattress suture configuration for meniscus repair. 1 https://pubmed.ncbi.nlm.nih.gov/23340094/ # SE Analysis 2: # Specification and Dimensions: During the bench testing of subject device, it was observed that the changes in dimensions are not leading to any kind of new risks with the performance of subject device, and the acceptance criteria was met in each of the performance tests as per defined guidelines and applicable standards. By considering the performance data of the subject device, it is evident that the changes in dimensions are not causing and or does not affect the safety and efficacy of the product when comparing it with Predicate device. The different sizes of the subject device are determined through the diameter of the dispenser which is not implantable in nature, however, there is no change in the size of the implant, so the variation in sizes of the dispenser will not lead to any kind of new risks related to safety and performance. #### 1.7. Summary of Performance Data The pull-out strength and displacement under cyclic loading of STATIV® Knotted UHMWPE Suture Anchor and Predicate device. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the STATIV® Knotted UHMWPE Suture Anchor and the predicate device. #### 1.8. Clinical Testing Not Applicable #### 1.9. Conclusion There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device (Arthrex FiberTak Suture Anchor) in design, Intended use, Indications for use, function, Sterilization method, Shelf Life, and operational principles. From the data available we can justify that the STATIV® Knotted UHMWPE Suture Anchor is as safe, and as effective and performs the same indications for use as that of already marketed predicate device identified in 1.3 of 510(k) summary. | Healthium Medtech Limited | | |----------------------------------------------------------------------------------------------------|-------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India | | | www.healthiummedtech.com CIN : U03311KA1992PLC013831 | Page 7 of 7 |