(30 days)
The Arthrex FiberTak 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:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• 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)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular labral repair.
The Arthrex FiberTak 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 or double loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for single use.
The provided text is a 510(k) Summary for the Arthrex FiberTak Suture Anchor. It describes a medical device, not an AI/ML powered device, therefore, the information requested in the prompt is not available in the provided text. The submission is for a line extension of an existing predicate device and focuses on establishing substantial equivalence through mechanical testing, not through clinical or reader studies involving AI.
Specifically, the document states:
- Purpose of Submission: "This Special 510(k) premarket notification is submitted to obtain clearance for the self-punching Arthrex FiberTak Suture Anchor as a line extension to the Arthrex FiberTak Suture Anchor devices cleared under K181769."
- Performance Data: "Ultimate load and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate."
Therefore, I cannot extract information related to acceptance criteria and studies proving the device meets those criteria from an AI/ML perspective because this is a mechanical device submission.
If you have a document describing an AI/ML powered medical device, I would be happy to provide the requested information.
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March 12, 2020
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Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K200341
Trade/Device Name: Arthrex FiberTak 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: February 4, 2020 Received: February 11, 2020
Dear Ms. Singelais:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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.
Laura C. Rose, PhD Acting Assistant 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
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Indications for Use
510(k) Number (if known)
K200341
Device Name Arthrex FiberTak Suture Anchor
Indications for Use (Describe)
The Arthrex FiberTak 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:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• 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)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
· Hip: Acetabular labral repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 | March 10, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Jessica L. SingelaisRegulatory Affairs Specialist1-239-598-4302, ext. 73091Jessica.singelais@arthrex.com |
| Name of Device | Arthrex FiberTak Suture Anchor |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K181769: Arthrex FiberTak Suture Anchor |
| Reference Device | K160319: Arthrex FiberTak DR Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for theself-punching Arthrex FiberTak Suture Anchor as a line extension to the ArthrexFiberTak Suture Anchor devices cleared under K181769. |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to beused 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 or doubleloaded suture component composed of UHWMPE or a polyblend of UHMWPE andpolyester. The anchor is preloaded on a disposable inserter and will be sold sterile forsingle use. |
| Indications for Use | The Arthrex FiberTak Suture Anchor is intended for fixation of suture (softtissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in thefollowing procedures:Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shiftor Capsulolabral ReconstructionHand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction ofcollateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP andMCP joints for all digits, digital tendon transfers, Carpal LigamentReconstruction and Carpometacarpal joint arthroplasty (basal thumb jointarthroplasty)Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendontransfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesisHip: Acetabular labral repair. |
| ComparisonSummary ofTechnological | The proposed device is a line extension to the predicate device. The proposed andpredicate devices (K181769) have the same basic design, intended use, indications foruse, packaging, shelf life and sterilization method. Proposed modifications consist of |
| Characteristics andModificationsProposed | a self-punching inserter and self-bunching mechanism. Any differences between theproposed device and the predicate device are considered minor and do not raisequestions concerning safety or effectiveness. |
| Performance Data | Ultimate load and pyrogenicity testing was conducted on a representative device andcompared to the predicate device to demonstrate that the proposed devices aresubstantially equivalent to the predicate. |
| Conclusion | The proposed Arthrex FiberTak Suture Anchors are substantially equivalent to thepredicate device in which the basic design features and intended uses are the same.Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the Arthrex FiberTak is substantiallyequivalent to the currently marketed predicate device. |
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§ 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.