ARTHREX TENODESIS FAMILY by ARTHREX, INC.

The Arthrex Tenodesis Family of screws, made of various metals and polymers which are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist

Device Description

The Arthrex Tenodesis Family of screws are manufactured using a variety of polymers or titanium metal. They are threaded, fully cannulated anchors with a rounded head. The Tenodesis Screws are available with specific instrumentation to aide implantation.

AI/ML Overview

This document describes a 510(k) premarket notification for the Arthrex Tenodesis Family of screws. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria for device performance as would be expected for novel devices or those undergoing a PMA.

Therefore, the requested information regarding acceptance criteria, device performance, and study details (like sample size, ground truth, expert involvement, and MRMC studies) for proving the device meets acceptance criteria is not applicable in the context of this 510(k) summary.

A 510(k) submission focuses on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The FDA's letter explicitly states: "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 of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."

Instead of clinical performance acceptance criteria, the "acceptance criteria" here relate to the regulatory requirements for demonstrating substantial equivalence. The "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, which primarily includes comparisons to predicate devices based on materials, design, and intended use.

Here's a breakdown of what can be inferred from the provided text, and where the requested information is not available due to the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Regulatory): The primary acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing the device has the same intended use and technical characteristics, or if different, that these differences do not raise new questions of safety and effectiveness.
Reported Device Performance: The document states: "The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices." This is the core "performance" claim in a 510(k) context – that it performs equivalently safely and effectively to the predicates.

Acceptance Criterion (Regulatory)	Reported Device Performance
Device is substantially equivalent to predicate devices.	"The Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices." The FDA concurred with this assessment in their letter.
Same intended use as predicate devices.	The intended use for the Arthrex Tenodesis Family (fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist) is deemed substantially equivalent to predicate devices.
Similar technological characteristics to predicate devices.	The description of the device (threaded, fully cannulated anchors with a rounded head, made of polymers or titanium metal) and its use with specific instrumentation implies similar technological characteristics to existing predicate suture anchors/fixation fasteners. The submission argues that any differences do not raise new safety or effectiveness concerns, and material characteristics are well-established.
Materials are well characterized and previously used in predicates.	This is explicitly stated: "Furthermore, the materials are well characterized and have been used in predicate devices with similar indications." This supports the safety and effectiveness claim.
No new questions of safety or effectiveness raised by differences.	This is the final conclusion made by the manufacturer and accepted by the FDA: "The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant." Further, the FDA's approval letter states the device "is substantially equivalent... to legally marketed predicate devices" and "do not require approval of a premarket approval application (PMA)."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. A 510(k) submission typically does not rely on a "test set" of patient data in the way a clinical trial for a novel device would. Instead, it relies on engineering assessments, material characterizations, and comparison to existing predicate devices. No new clinical study data with test sets, patient numbers, or data provenance is mentioned or required for this type of submission.

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

Not Applicable. No "test set" or ground truth requiring expert review is described in this 510(k) summary. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication method is mentioned.

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 device is a surgical implant (suture anchor), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are wholly irrelevant.

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

Not Applicable. As above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable in the traditional sense. The "ground truth" for a 510(k) lies in the established safety and effectiveness of the identified predicate devices, which have already undergone regulatory scrutiny or have a long history of safe use in the market. The submission argues the new device is comparable to this established "truth."

8. The sample size for the training set

Not Applicable. No training set for an algorithm is involved.

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

Not Applicable. No training set is involved.

Summary

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K05-1726 pg192

SEP 2 7 2005

510(k) Summary

510(k) Number:		Arthrex, Inc.
Company:
Address:		1370 Creekside Blvd., Naples, FL 34108-1945
Telephone:		(239) 643-5553
Facsimile:		(239) 598-5508
Contact:		Ann Waterhouse
Trade Name:		Arthrex Tenodesis Screw Family
Common Name:		Suture Anchor
Classification:		Fastener, Fixation
Product Code:		HWC, MAI, MBI

Description:

Indications for Use:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction

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page 242

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH AND HUMAN SERVICES" at the bottom and "USA" at the top.

SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex, Incorporated 1370 Creekside Boulevard Naples, Florida 34108

Re: K051726

Trade/Device Name: Arthrex Tenodesis Family Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: September 15, 2005 Received: September 19, 2005

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premated is substantially equivalent (for the indications
referenced above and have determined the device is subsets marketed in intersta referenced above and have decemblicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chactinent and other of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval provinces of the Act . The and Cosmetic Act (Act) that do not require upproval controls provisions of the Act. The Act. The Act. The You may, merelore, market the device, sayed to use include registration, listing of
general controls provisions of the Act include requirements michscanding and general controls provisions of the Frec merator required in the manage inst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Tixis A. R. A. A. addition FDA may be subject to such additional controlis: Extrems, be found in the Code of Peacharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substance or substition of the Act
that FDA has made a determination that your device complies with onemaiss. You must that FDA has made a delemination that your ac-ries by other Federal agencies. You must or any Federal statutes and regulations administers or registration and listing (21 l
comply with all the Act's requirements, including, but not his requirements as set comply with an the Act s requirements, more and manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if caplicable, th CFR Part 807); labeling (21 CFR 1 at 601); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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Page 2- Ms. Ann Waterhouse, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manet.ing of substantial equivalence of your device to a legally prematicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spochie advision at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Compination" (21CFR Part 807.97). You may obtain. Nusofanding of Terefores to presessibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html

Sincerely yours,
Mark A. Milikan

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Arthrex Tenodesis Family

Indications for Use:

Indications Tor USC.
The Arthrex Tenodesis Screws are constructed of various polymers and metals The Antirex Tenodols Ooft tissue reatachment, i.e. fixation of lighthis and and intended to provide ook toous foomlooder, elbow, knee, footlankle, and hand/wrist. Specifically;

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Kotator Out Ropaire, Bavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Eatchar Otablization, Midfoot Reconstruction, Metatarsal Hallax Valgair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Antonol - Graciato - Graciato - Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction, Reconstruction, (coonstracarpal joint arthroplasty (basal thumb joint arthroplasty), Carpornotations Reconstructions and repairs, tendon transfer in the hand/ wrist

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

Subpart C)

Concurrence of CDRH, Office of Device Evalyation (ODE)

Mark Millican

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051726

page 1 of

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.