Who is the manufacturer of OsteoFab Suture Anchors?

Oxford Performance Materials, Inc. filed the 510(k) submission for OsteoFab Suture Anchors (K190915).

What is the FDA product code for OsteoFab Suture Anchors?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for OsteoFab Suture Anchors?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OsteoFab Suture Anchors?

Cayenne Quattro Link Knotless Anchors (K122314).

Who can help prepare an FDA 510(k) submission like OsteoFab Suture Anchors?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OsteoFab Suture Anchors

K190915 · Oxford Performance Materials, Inc. · MBI · Jul 3, 2019 · Orthopedic

Device Facts

Record ID	K190915
Device Name	OsteoFab Suture Anchors
Applicant	Oxford Performance Materials, Inc.
Product Code	MBI · Orthopedic
Decision Date	Jul 3, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair. Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis. Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair. Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair. Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.

Device Story

OsteoFab® Suture Anchors are single-procedure implants for reattaching soft tissue to bone; used in shoulder, knee, hand, wrist, elbow, and foot/ankle surgeries. Device consists of PEKK polymer anchor, manufactured via proprietary additive manufacturing process; available in 4.5mm, 5.5mm, and 6.5mm sizes. Surgeon mounts anchor on custom inserter, threads with suture, and deploys into bone via interference fit. Device provides mechanical fixation of soft tissue to bone, facilitating healing. Used in clinical settings by orthopedic surgeons. Benefits include secure soft tissue reattachment using biocompatible PEKK material.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing (insertion, static pullout, fatigue) and biological safety assessment (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, genotoxicity, implantation, chronic toxicity, carcinogenicity, and endotoxin testing).

Technological Characteristics

Material: Polyetherketone (PEKK). Manufacturing: Additive manufacturing process. Design: Optimized for interference fit in bone. Sizes: 4.5mm, 5.5mm, 6.5mm. Provided non-sterile.

Indications for Use

Indicated for fixation/reattachment of soft tissue to bone in shoulder, knee, hand, wrist, elbow, foot, and ankle procedures.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Cayenne Quattro Link Knotless Anchors (K122314)

Submission Summary (Full Text)

{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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". July 3, 2019 Oxford Performance Materials, Inc. Mr. Andrus Maandi Product Development Engineer 30 South Satellite Road South Windsor, Connecticut 06074 # Re: K190915 Trade/Device Name: OsteoFab® Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 8, 2019 Received: April 9, 2019 ## Dear Mr. Maandi: 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 medical devices and radiation-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 Laurence Coyne, Ph.D. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K190915 Device Name OsteoFab® Suture Anchors ### Indications for Use (Describe) The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair. Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis. Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair. Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair. Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy. Type of Use (Select one or both, as applicable) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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 spect 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/1 description: The image shows a logo with the letters OPM. The "O" is represented by an orange circle inside a diamond shape. The "P" is represented by a black letter inside a circle and square. The "M" is represented by an orange letter inside a triangle and square. # 005 – 510(k) Summary [As required by 21 CFR 807.92] | I. Submitter | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner: | Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074 USA Phone: (860)-698-9300 Fax: (860)-698-9978 | | Submitter/Contact: | Andrus Maandi Product Development Engineer Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074 USA Phone: (860)-656-9437 | | Date Prepared: | April 17, 2019 | | II. Device | | | Proprietary Name: | OsteoFab® Suture Anchors | | Common or Usual Name: | Bone anchors, suture anchors | | Classification: | 21 CFR 888.3040; Smooth or threaded metallic bone fixation fastener | | Regulatory Class: | Class II | | Product Code: | MBI | | Review Panel: | Orthopedic | ## III. Predicate Device K122314 Cayenne Quattro Link Knotless Anchors Predicate Device: ## IV. Device Description The OsteoFab® Suture Anchor is a single procedure suture anchor device for the reattachment of soft tissue to bone in shoulder, knee, hand and wrist, elbow, and foot and ankle procedures. This reattachment of damaged soft tissue is achieved with suture that is threaded through an anchor which is fixated in bone via interference fit between the anchor and bone. The anchor is mounted on a custom inserter and threaded with recommended suture before deployment. The OsteoFab® Suture Anchors are manufactured from polyetherketone (PEKK) polymer in Oxford Performance Materials, Inc.'s proprietary additive manufacturing process. The OsteoFab® Suture Anchors are available in three sizes (4.5, 5.5, ad 6.5mm) and are provided non-sterile. {4}------------------------------------------------ ## Intended Use Statement The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair. Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis. Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair. Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair. Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy. # V. Comparison of Technological Characteristics with the Predicate Device Principle of Operation The basic operational principle of the OsteoFab® Suture Anchors is the same as the predicate: the operating principle of the OsteoFab® Suture Anchors is to fixate/reattach soft tissue to bone. ## Technological Characteristics The technological characteristics of the OsteoFab® Suture Anchor devices are similar to the predicate device in terms of operating principle and intended use. The OsteoFab® Suture Anchors are deployed into a pilot hole using a custom inserter and recommended suture in order to secure soft tissue to bone. Any differences in technological characteristics are summarized below: - । Design: optimized design for additive manufacturing with same general characteristics to achieve a secure interference fit in bone. - । Material: polyetherketone (PEKK) is used instead of polyetheretherketone (PEEK). - Manufacturing method: OsteoFab® Suture Anchors are manufactured in an additive । process compared to conventional machining. {5}------------------------------------------------ # VI. Performance Data For determination of substantial equivalence, insertion testing, pullout testing, and fatigue testing were performed. Mechanical testing showed that the mechanical strength and function of the subject device is substantially equivalent to the legally marketed predicate device and that it is sufficient for the intended use. A biological safety assessment was also performed that demonstrated that the subject device is biocompatible for long term implantation and substantially equivalent to the legally marketed predicate device. ## Performance Bench Testing The following performance bench tests were completed: - । Insertion testing - । Static pullout testing - Fatigue testing । ## Animal Testing Animal testing was not required as a basis for substantial equivalence. ## Clinical Testing Clinical testing was not required as a basis for substantial equivalence. ## Biocompatibility Testing A biological safety assessment was performed that evaluated endpoints including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity. Endotoxin testing was also performed. ## Sterilization and Cleaning Sterilization and cleaning instructions in the subject device labeling are provided per validated methods and parameters. ## VII. Substantial Equivalence Conclusion This submission supports the position that the subject implants are substantially equivalent to the previously cleared predicate devices. The subject and predicate devices are similar in terms of indications for use, operating principles, technological characteristics, and mechanical strength. There are no significant differences between the subject and predicate device that would affect the safety and effectiveness of the OsteoFab® Suture Anchors. Any differences were not considered significant based on the data provided in this submission.

OsteoFab Suture Anchors

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

OsteoFab Suture Anchors

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps