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, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• 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)
• 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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

Device Description

The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor 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 sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic or prognostic tool.

Therefore, many of the requested elements regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, and standalone performance for an AI/algorithm are not applicable to this document. This document details the physical characteristics of a mechanical medical device and its performance through mechanical testing and biocompatibility assessment.

However, I can extract information related to the performance data and the comparison to the predicate device, which serves a similar function to demonstrating "acceptance criteria" in the context of a 510(k) submission for a physical device.

Here's the information that can be extracted from the provided text, and where gaps exist due to the nature of the document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Measured Performance)	Reported Device Performance (Arthrex FiberTak Suture Anchor)
Mechanical Strength (Cyclic Pull-out Testing)	Statistically equivalent to the primary predicate device (K221396)
Pyrogenicity (Bacterial Endotoxin per EP 2.6.14/USP <85>)	Meets pyrogen limit specifications
Biocompatibility	Identical biocompatibility profile to the primary predicate device (K221396)
Sterility (Ethylene Oxide)	Provided sterile, single-use, packaged in a 5-pack

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the sample size used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was conducted."
Data Provenance: The data was generated by Arthrex Inc. in the context of demonstrating substantial equivalence for their new device. There is no mention of country of origin of the data or whether it was retrospective or prospective in the context of a clinical study, as this is a device performance test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a mechanical device, and "ground truth" is established through physical testing standards and specifications (e.g., measured pull-out strength, endotoxin levels), not expert interpretation of diagnostic images or data.

4. Adjudication method for the test set:

Not Applicable. As above, mechanical tests do not involve adjudication by multiple human experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This document pertains to a physical medical device (suture anchor), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by engineering and material science standards and specifications. For example:
- Mechanical strength: Measured values from cyclic pull-out tests that are compared against predefined performance benchmarks or the performance of a legally marketed predicate device.
- Biocompatibility: Demonstrated through adherence to established biocompatibility testing standards (e.g., ISO 10993) and comparison to a predicate device with a known biocompatibility profile.
- Sterility: Demonstrated through validated sterilization processes and testing to ensure compliance with sterility assurance levels.
- Pyrogenicity: Demonstrated by a bacterial endotoxin test meeting specified limits.

8. The sample size for the training set:

Not Applicable. This is not an AI/algorithm device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/algorithm device.

Summary of the study proving the device meets the "acceptance criteria" (i.e., substantial equivalence):

The study described is a performance testing study primarily focused on cyclic pull-out testing and bacterial endotoxin testing.

Purpose: To demonstrate that the new Arthrex FiberTak Suture Anchor performs equivalently to its primary predicate device (K221396) and meets safety specifications.
Methodology:
- Cyclic Pull-out Testing: Performed on the new device. The results were then compared statistically to the performance of the predicate device (K221396). The document states the new device "performs statistically equivalent to the primary predicate device."
- Bacterial Endotoxin Testing: Conducted per EP 2.6.14/USP <85> to ensure the device meets pyrogen limit specifications.
- Technological Comparison: The submission also relies on a detailed technological comparison, stating that the subject device is a line extension with "identical basic design, indications for use, intended use, packaging, shelf-life, biocompatibility profile, overall manufacturing, and sterilization processes" to the predicate. The only stated modification is to the pre-loaded sutures, and this difference is considered minor, not raising new questions of safety or effectiveness.
Conclusion: Based on the performance data and technological comparison, Arthrex determined that the subject device is substantially equivalent to the currently marketed primary predicate device, implying it meets the necessary performance and safety criteria for its intended use.

Summary

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March 28, 2025

Arthrex Inc. Ruth Segall Regulatory Affairs Specialist II 1370 Creekside Blvd Naples, Florida 34108

Re: K250596

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 27, 2025 Received: February 28, 2025

Dear Ruth Segall:

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.

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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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Thomas Mcnamara -S

For: Christopher Ferreira, MS 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

Submission Number (if known)

K250596

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, SLAP Lesion 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 Collateral Ligament Repair, Patellar Tendon

Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure

· Hip: Capsular Repair, Acetabular Labral Repair, 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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Image /page/4/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a sans-serif font, with the "x" stylized to resemble a surgical instrument. The logo is simple and modern, and it is likely used to promote the company's products and services.

510(k) Summary

Date Prepared	02/27/2025
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Ruth SegallTitle: Regulatory Affairs Specialist IIPhone: 239-598-4302 x 71764Email: Ruth.Segall@arthrex.com
Trade Name	Arthrex FiberTak Suture Anchor
Common Name	Suture Anchor
Product Code	MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener
Regulatory Class	Class II
Primary Predicate Device	K221396: Arthrex FiberTak Suture Anchor
Additional Predicate Devices	N/A
Reference Devices	K230433: Arthrex Double Loaded Knotless FiberTak®Suture AnchorK193157: Arthrex 3.9 Corkscrew Suture Anchor
Purpose of Submission	This Special 510(k) premarket notification is submittedto obtain clearance for the subject Arthrex FiberTakSuture Anchor as a line extension to the ArthrexFiberTak Suture Anchor cleared via K221396.
Device Description	The Arthrex FiberTak Suture Anchor is an all-sutureknotless anchor intended to be used for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle,knee, hand/wrist, elbow, and hip.The anchor is constructed from a hollow braid sheathmade of polyester yarns with Arthrex suturecomponents assembled to the sheath. The suturecomponents include a repair suture and a passingsuture which are braided polyester sutures made ofultra-high molecular weight polyethylene (UHMWPE)
	where the suture may also include nylon yarns. Theanchor is preloaded on a disposable inserter andis provided sterile (Ethylene Oxide), single-use, and ispackaged in a 5-pack.
Indications for Use	The Arthrex FiberTak Suture Anchor is intended forfixation of suture (soft tissue) to bone in the shoulder,foot/ankle, knee, hand/wrist, elbow, and hip in thefollowing procedures:• Elbow: Biceps Tendon Reattachment, Ulnar or RadialCollateral Ligament Reconstruction• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAPLesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction• Hand/Wrist: Scapholunate Ligament Reconstruction,Repair/Reconstruction of collateral ligaments, Repair ofFlexor and Extensor Tendons at the PIP, DIP and MCPjoints for all digits, digital tendon transfers, CarpalLigament Reconstruction and Carpometacarpal jointarthroplasty (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, LateralCollateral Ligament Repair, Patellar Tendon Repair,Posterior Oblique Ligament Repair, Iliotibial BandTenodesis, Joint Capsule Closure• Hip: Capsular Repair, Acetabular Labral Repair, GlutealTendon Repair
Performance Data	Cyclic pull-out testing was conducted on the subjectArthrex FiberTak Suture Anchor submitted in thisSpecial 510(k). The test data demonstrates that thesubject device performs statistically equivalent to theprimary predicate device.Bacterial endotoxin per EP 2.6.14/USP <85> wasconducted to demonstrate that the device meetspyrogen limit specifications.
Technological Comparison	The subject Arthrex FiberTak Suture Anchor is a lineextension to the primary predicate device K221396. Thesubject and primary predicate devices have identicalbasic design, indications for use, intended use,packaging, shelf-life, biocompatibility profile, overallmanufacturing, and sterilization processes. Incomparison to the predicate device, the subject devicecontains a modification to the pre-loaded sutures. Anydifferences between the subject and predicate devicesare considered minor and do not raise any questionsconcerning safety or effectiveness.
Conclusion	The Arthrex FiberTak Suture Anchor is a line extensionand substantially equivalent to the predicate device(K221396) in which the basic design features,indications for use and intended use are identical. Anydifferences between the subject device and the primarypredicate devices are considered minor and do notresult in new or different questions concerning safety oreffectiveness. Based on the indications for use,technological characteristics, and the summary of datasubmitted, Arthrex has determined that the subjectdevice is substantially equivalent to the currentlymarketed primary predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the text is an image of a surgical instrument, possibly a type of clamp or forceps. The instrument is stylized and simplified, with a handle and a grasping end.

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Image /page/6/Picture/1 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical tool, possibly a type of clamp or scissor. The logo is simple and professional, and it is likely used to represent the company's brand.

Regulation Number and Section

§ 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.