The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Device Description

The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading anchor configured with suture or with suture and needles.

AI/ML Overview

This K043337 submission for the Arthrex Bio-Corkscrew Suture Anchor is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device). For devices cleared via 510(k), especially for general orthopedic fixation devices like suture anchors, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to a predicate device's performance, rather than through a rigorous, AI-specific performance study with pre-defined acceptance criteria and ground truth validation. This clearance relies on the established safety and effectiveness of the predicate.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in a 510(k) submission for this type of device, as it does not involve an AI/ML algorithm or a new performance claim that requires such a study design.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (General to 510(k) process):

Same Intended Use: The new device must have the same intended use as a legally marketed predicate device.
Same Technological Characteristics: The new device must have the same technological characteristics as the predicate, OR different technological characteristics must not raise new questions of safety and effectiveness.
No New Questions of Safety and Effectiveness: Any differences in technological characteristics must be demonstrated to be as safe and effective as the predicate.

Reported Device Performance (as per the 510(k) Summary):

Criterion	Reported Performance of Arthrex Bio-Corkscrew Suture Anchor
Intended Use	Fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. (Same as predicate)
Technological Characteristics	• Material: Biodegradable (MAI Fastener, Fixation, Biodegradable, Soft Tissue) and Nonabsorbable Synthetic Polyethylene Suture. • Design: 5.5 x 15mm fully threading, configured with suture or with suture and needles. • Function: Suture anchor for bone fixation. (Described as having "the same basic features and intended uses" as the predicate Arthrex Bio-Corkscrew Suture Anchor. Minor differences are stated to "not raise questions concerning safety and effectiveness.")
Safety and Effectiveness	The submission states that "minor differences between the Arthrex Bio Corkscrew Suture Anchor and the predicate Arthrex Bio-Corkscrew Suture Anchor are considered minor and do not raise questions concerning safety and effectiveness." This is based on the provided information and comparison to the predicate device K003227 & K990987. The FDA concurred with this assessment.

2. Sample Size Used for the Test Set and the Data Provenance

Not applicable: This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/ML algorithm or a performance study requiring such a sample size. The substantial equivalence relies on comparison to a predicate device and potentially non-clinical bench testing (but details of such testing are not provided in the summary).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable: No "ground truth" was established for a test set in the context of an AI/ML or diagnostic performance study as described in the provided document.

4. Adjudication Method for the Test Set

Not applicable: There was no test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: An MRMC comparative effectiveness study was not done, as this is a medical device for physical fixation, not an image analysis or diagnostic AI tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable: This device is a physical suture anchor, not an algorithm.

7. The Type of Ground Truth Used

Not applicable: No "ground truth" data of the type requested (expert consensus, pathology, outcomes data) was used in this 510(k) submission for the purpose of validating an AI/ML model or a new diagnostic claim. The "ground truth" for substantial equivalence is effectively the performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

Not applicable: This submission does not involve a "training set" for an AI/ML model.

9. How the Ground Truth for the Training Set Was Established

Not applicable: This submission does not involve an AI/ML model or a training set requiring ground truth establishment.

Summary

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K043337

DEC 1 4 2004

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IX.

ARTHREX BIO-CORKSCREW SUTURE ANCHOR

MANUFACTURER / SPONSOR

Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Sally Foust, RAC 510(K) CONTACT: Sr. Regulatory Affairs Specialist Telephone: (239) 643-5553 ext. 1251 FAX: (239) 598-5539

TRADE NAME:

COMMON NAME: PRODUCT CODE / CLASSIFICATION NAME Bio-Corkscrew Suture Anchor

Fastener; Screw, Fixation, Bone; Suture

MAI Fastener, Fixation, Biodegradable, Soft Tissue

21 CFR 888.3040 / HWC Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener

21 CFR 888.5000 Suture, Nonabsorbable Synthetic Polyethylene

PREDICATE DEVICE:

Bio-Corkscrew Suture Anchor: K003227 & K990987

DEVICE DESCRIPTION AND INTENDED USE:

DEVICE DESCRIP TION AND INTENDED GOL:
The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading The Althrox Blo Gonfigured with suture or with suture and needles.

The Arthrex Bio-Corkscrew Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.

SUBSTANTIAL EQUIVALENCE SUMMARY

SUBSTANTIAL EQUIVALENGE OOMMAx : :
The Arthrex Bio-Corkscrew Suture Anchor is substantially equivalent to the same - Any The Antifies Dio-Oorksolow Guture Anohor in the basic features and intended uses are the same. Any Corkscrew Suture Anonor in which the Backsonew Suture Anchor and the predicate Arthrex Blodifferences between the Arthex Blo Serkoron and do not raise questions concerning safety and Corkscrew Sature Anchor are Scholored miner and be and the producted producted producted producted products dovice ellectivelless: Dased on the midner outmation one interestly marketed predicate device.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Ms. Sally Foust, RAC Sr. Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108

Re: K043337

Trade/Device Name: Arthrex Bio-Corkscrew FT Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 2, 2004 Received: December 3, 2004

Dear Ms. Foust:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your Section 310(t) premiented in substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans manative province to the Medical Device American France Free d. Bruss connitieres provision to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval apploval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, mercrore, market the device, equirements for annual registration, listing of general controls provisions of arctice, labeling, and prohibitions against 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 (500 above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controllar entires of Parts 800 to 898. In addition, FDA may be found in the Outsting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe advised that 1 Dri- 3 issuation or a cases of the other requirements of the Act that 117A has made a colorimiation administered by other Federal agencies. You must of any reactal statutes and regulations and limited to: registration and listing (21 Comply with an the 7te of requirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Sally Foust, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
O Mark n Malle

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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III. INDICATIONS FOR USE FORM

Indications for Use

510(k) Number (if known):	K043337
Device Name:	Arthrex Bio-Corkscrew FT Suture Anchor
Indications for Use:

The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the The Arthrex Bio-Corkscrew FT Suture Anchor is intended for Sublish of Sublished
shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the followin procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular
Shoulder: Repair, M. Bearly Consuler Shift or Capsulolabral Reconstru Shoulder: Rotator Cuff Repairs, Bankari Repair, OEA. Editor Repair, Capsulolabral Reconstruction.
Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconst

Start - Allus Lateral Stabilization, Medial Stabilization, Achiles Tendon Repair, Hallux Valgus Reconstruction, Me Pool Affikie. Lateral Oldomballianal Ligament Repair.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament
Production Collection Contacter Chlique Ligament Repair, and lligtib Knee: Anterior Cruciate Ligament Repair, Medial Collateral Elganent Repair, List Collection
Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial
eral Collection, Factor, Liga Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Prescription Use
AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1_

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.