Arthrex FiberTak Suture Anchor

K231113 · Arthrex, Inc. · MBI · May 18, 2023 · Orthopedic

Device Facts

• Record ID: K231113
• Device Name: Arthrex FiberTak Suture Anchor
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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: · Shoulder: Rotator cuff repair, Bankart 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, and joint capsule closure, and Medial Patellofemoral Ligament Repair/Reconstruction · Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament 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 epicondy.itis repar · Hip: Gluteal tendon repair

Device Story

All-suture anchor device; used for soft-tissue-to-bone fixation. Constructed from hollow polyester braid; pre-loaded with UHMWPE or UHMWPE/polyester blend suture. Sold sterile for single-use; includes disposable inserter. Operated by surgeons in clinical/OR settings. Device inserted into bone to anchor soft tissue; provides mechanical fixation for various orthopedic repairs (e.g., rotator cuff, ligament reconstruction). Benefits patient by enabling secure tissue reattachment during surgical procedures.

Clinical Evidence

Bench testing only. Mechanical pull-out (tensile) strength testing demonstrated that the device meets criteria established by published literature for Medial Patellofemoral Ligament Repair/Reconstruction.

Technological Characteristics

All-suture anchor; hollow polyester braid; UHMWPE or UHMWPE/polyester blend suture. Disposable inserter. Sterile, single-use. Same design, materials, and sterilization as predicate.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip procedures, including specific ligament, tendon, and joint repairs/reconstructions.

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

• Arthrex FiberTak Suture Anchor (K203268)

Reference Devices

• Arthrex SwiveLok Suture Anchor (K201749)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Arthrex Inc. Kristi Frisch Regulatory Affairs Specialist, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945

## Re: K231113

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: April 17, 2023 Received: April 19, 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 (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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

Yu-chieh Chiu -S

Digitally signed by Yuchieh Chiu -S Date: 2023.05.17 20:21:18 -04'00'

Yu-Chieh Chiu, Ph.D. 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) K231113

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:

· Shoulder: Rotator cuff repair, Bankart 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, and joint capsule closure, and Medial Patellofemoral Ligament Repair/Reconstruction

• Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament 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 epicondy.itis repar

· Hip: 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 | May 18, 2023 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Kristi Frisch<br>Regulatory Affairs Specialist, Principal<br>Tel [phone] x73849<br>[e-mail] |
| Trade Name | Arthrex FiberTak 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 | K203268: Arthrex FiberTak Suture Anchor |
| Reference Device(s) | K201749: Arthrex SwiveLok Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to expand<br>indications of the 2.6 mm FiberTak Suture Anchor to include Medial<br>Patellofemoral Ligament Repair/Reconstruction. |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device<br>intended to be used for fixation of suture (soft tissue) to bone in the<br>shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.<br>The anchor is constructed from a hollow braid of polyester with a single<br>loaded suture component composed of UHWMPE or a polyblend of<br>UHMWPE and polyester.<br>The anchor is pre-loaded on a disposable inserter and will be sold sterile<br>for single-use |
| Indications for Use | The Arthrex FiberTak Suture Anchor is intended for fixation of suture<br>(soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist,<br>elbow, and hip in the following procedures:<br>Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair,<br>biceps tenodesis, acromio-clavicular separation repair, deltoid<br>repair, capsular shift or capsulolabral reconstruction Foot/Ankle: Lateral stabilization, medial stabilization, achilles<br>tendon repair, mid-foot reconstruction, hallux valgus<br>reconstruction, metatarsal ligament repair, and digital tendon<br>transfers Knee: Medial collateral ligament repair, lateral collateral ligament<br>repair, patellar tendon, posterior oblique ligament repair, iliotibial<br>band tenodesis, joint capsule closure, and Medial Patellofemoral<br>Ligament Repair/Reconstruction Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament<br>reconstructions, repair/reconstruction of collateral ligaments<br>digital tendon transfers, and carpometacarpal joint arthroplasty<br>(basal thumb joint arthroplasty Elbow: Biceps tendon reattachment, ulnar/radial collateral<br>ligament reconstruction, and lateral epicondylitis repair |

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| Performance Data | Mechanical testing demonstrated that the pull-out (tensile) strength of<br>the proposed Arthrex FiberTak Suture Anchor met the criteria<br>established by published literature for Medial Patellofemoral Ligament<br>Repair/Reconstruction. |
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| Technological Comparison | The proposed Arthrex Suture Anchor device and predicate device<br>(K203268) have the same technological characteristics (device design,<br>sterilization and biocompatibility). The proposed device modification<br>consists of the addition of the Medial Patellofemoral Ligament<br>Repair/Reconstruction indication.<br>The Arthrex FiberTak Suture Anchor is substantially equivalent to the<br>predicate device in which the design features and intended uses are the<br>same.<br>Any differences between the proposed device and the predicate device<br>are considered minor and do not raise questions concerning safety or<br>effectiveness. |
| Conclusion | The Arthrex FiberTak Suture Anchor is substantially equivalent to the<br>predicate devices cleared under K203268 in which the basic design<br>features and intended use are the same. Any differences between the<br>Arthrex FiberTak Suture Anchor and the predicate devices are<br>considered minor and do not raise different questions of safety or<br>effectiveness. |
| Conclusion | The submitted mechanical testing data demonstrates that the Arthrex<br>FiberTak Suture Anchor is substantially equivalent to that of the<br>predicate devices for the desired indication. |
| Conclusion | Based on the indications for use, technological characteristics, and the<br>summary of data submitted, Arthrex Inc. has determined that the<br>proposed device is substantially equivalent to the currently marketed<br>predicate devices. |