(55 days)
The Arthrex Knee FiberTak® Button Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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
Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers
Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair
Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair
The Arthrex Knee FiberTak® Button Suture Anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester.
The anchor is pre-loaded on a disposable inserter and will be sold sterile for single use
The provided text is a 510(k) Summary for the Arthrex Knee FiberTak® Button Suture Anchor, specifically for an expanded indication for quadriceps tendon repair. This document describes a medical device and its regulatory clearance process, not an AI or software-based device that would typically have the acceptance criteria and study detailed in the prompt.
Therefore, the information requested in your prompt (acceptance criteria, study details for a device meeting these criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies, etc.) is not present in the provided document. This document pertains to the mechanical and functional equivalence of a physical medical implant.
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November 15, 2023
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Arthrex Inc Kristi Frisch Regulatory Affairs Specialist, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K232973
Trade/Device Name: Arthrex Knee FiberTak® Button 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: September 19, 2023 Received: September 21, 2023
Dear Kristi Frisch:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232973
Device Name
Arthrex Knee FiberTak® Button Suture Anchor
The Arthrex Knee FiberTak® Button Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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
· Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers
• Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair
· Hand/Wrist: Scapholunate ligament reconstructions, repair/reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
· Elbow: Biceps tendon reattachment, ulnarradial collateral ligament reconstruction, and lateral epicondylitis repar
· Hip: Acetabular Labral Repair and gluteal tendon repair
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)
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510(k) Summary
| Date Prepared | November 14, 2023 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Kristi FrischRegulatory Affairs Specialist, PrincipalTel 239-598-4302 x73849Kristi.Frisch@Arthrex.com |
| Trade Name | Arthrex Knee FiberTak® Button Suture Anchor |
| Common Name | Suture Anchor |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Primary Predicate Device | K231330: Arthrex FiberTak® Suture Anchor |
| Additional Predicate Device | K180768 Arthrex BioComposite SwiveLock® |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to expandindications of the Arthrex Knee FiberTak® Button Suture Anchor toinclude quadriceps tendon repair. |
| Device Description | The Arthrex Knee FiberTak® Button Suture Anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) tobone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.The anchor is constructed from a hollow braid of polyester with a singleloaded suture component composed of UHWMPE or a polyblend ofUHMWPE and polyester.The anchor is pre-loaded on a disposable inserter and will be sold sterilefor single use |
| Indications for Use | The Arthrex Knee FiberTak® Button Suture Anchor is intended forfixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee,hand/wrist, elbow, and hip in the following procedures:Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair,biceps tenodesis, acromio-clavicular separation repair, deltoidrepair, capsular shift or capsulolabral reconstruction Foot/Ankle: Lateral stabilization, medial stabilization, achillestendon repair, mid-foot reconstruction, hallux valgusreconstruction, metatarsal ligament repair, and digital tendontransfers Knee: Medial collateral ligament repair, lateral collateral ligamentrepair, patellar tendon, posterior oblique ligament repair, iliotibialband tenodesis, joint capsule closure, medial patellofemoralligament repair/reconstruction, and quadriceps tendon repair Hand/Wrist: Scapholunate ligament reconstruction, carpal ligamentreconstructions, repair/reconstruction of collateral ligaments digitaltendon transfers, and carpometacarpal joint arthroplasty(basal thumb joint arthroplasty) Elbow: Biceps tendon reattachment, ulnar/radial collateral ligamentreconstruction, and lateral epicondylitis repair |
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| Performance Data | Ultimate load testing and cyclic displacement was performed on thesubject device to demonstrate that the differences do not negativelyimpact mechanical strength. |
|---|---|
| Technological Comparison | The proposed Arthrex Knee FiberTak® Button Suture Anchor device andpredicate device (K231330) have the same scientific technology,packaging, sterility, shelf-life, and MRI safety labeling. The proposeddevice modification consists of the addition of the quadriceps tendonrepair indication. The additional predicate device Arthrex BioCompositeSwiveLock® is comparable in design, intended use and inclusion of thequadriceps tendon repair indication.The Arthrex Knee FiberTak® Button Suture Anchor is substantiallyequivalent to the predicate device in which the design features andintended uses are identical.Any differences between the proposed device and the predicate deviceare considered minor and do not raise questions concerning safety oreffectiveness. |
| Conclusion | The Arthrex Knee FiberTak® Button Suture Anchor is substantiallyequivalent to the predicate devices cleared under K231330 in which thebasic design features and intended use are identical. Any differencesbetween the Arthrex Knee FiberTak® Button Suture Anchor and thepredicate devices are considered minor and do not raise differentquestions of safety or effectiveness.The submitted mechanical testing data demonstrates that the ArthrexKnee FiberTak® Button Suture Anchor is substantially equivalent to thatof the predicate devices for the desired indication.Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that theproposed device is substantially equivalent to the currently marketedpredicate devices. |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.