The Arthrex Tak™ Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
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, Carpal 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
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

Device Description

The Arthrex Tak™ Family is comprised of titanium alloy implants, poly (L-lactide) or PLLA implants and poly (L-lactide-Co-D, L-lactide) or PLDLA implants. They are offered in several different shapes and sizes. They are offered sterile.

AI/ML Overview

This 510(k) summary (K050749) describes a medical device, the "Arthrex Tak™ Family," which consists of fixation screws for orthopedic applications. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in studies for AI/software devices.

This document is a regulatory submission for a physical medical implant (bone fixation devices) and not an AI or software as a medical device (SaMD). Therefore, the questions related to clinical studies, ground truth, expert consensus, and reader performance with or without AI assistance are not applicable in this context.

The document primarily focuses on:

Device Description: The materials (titanium alloy, PLLA, PLDLA) and forms of the implants.
Indications for Use: The specific anatomical locations and procedures for which the Arthrex Tak™ Family is intended (e.g., foot, ankle, knee, shoulder, and maxillofacial applications).
Substantial Equivalence: The legal and regulatory argument that this device is comparable in safety and effectiveness to predicate devices already on the market. This is the primary method of "proving" its acceptability in a 510(k) submission for this type of device.

Therefore, I cannot provide the requested information for acceptance criteria and study details because this document does not describe such a study for this type of device. The FDA's 510(k) clearance process for physical medical devices like these bone fixation screws relies on demonstrating substantial equivalence to existing predicate devices, rather than conducting a new clinical study to establish performance metrics against specific acceptance criteria in the way an AI/software device would.

Summary

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MAY 1 2 2005 510(k) Summary

510(k) Number:	K050749
Company:	Arthrex, Inc.
Address:	1370 Creekside Blvd., Naples, FL 34108-1945
Telephone:	(239) 643-5553
Facsimile:	(239) 598-5508
Contact:	Ann Waterhouse
Device Name:	Arthrex TakTM Family
Classification:	Screw, Fixation, Bone
Product Code:	HWC, MAI, MBI (21 CFR 888.3040 and 888.3030)

Description:

Indications for Use:

Skull:	Stabilization and fixation of oral cranio-maxillofacial skeletal bone,mandible and maxillofacial bones, Lateral Canthoplasty, Repair ofNasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint(TMJ) reconstruction, soft tissue attachment to the parietal temporalridge, frontal, zygoma, and perioorbital bones of the skull
Elbow:	Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction
Shoulder:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist:	Scapholunate Ligament Reconstruction, Carpal LigamentReconstruction, Repair/Reconstruction of collateral ligaments,Repair of Flexor and Extensor Tendons at the PIP, DIP and MCPjoints for all digits, digital tendon transfers
Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgus reconstruction, digitaltendon transfers, Mid-foot reconstruction
Knee:	Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis

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Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications for use as well as the expanded indications noted in the above statement. These expanded indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials used in construction of these devices are well characterized and have been used in predicate devices with similar indications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings or feathers. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

MAY 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050749 Trade/Device Name: Arthex Tak™ 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: March 22, 2005 Received: March 23, 2005

Dear Ms. Waterhouse:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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) I ins letter will anow you to ough mationing of substantial equivalence of your device to a legally premarket notification: "The PDT Intention 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 specific advice for your acon 2011 276-0120 . Also, please note the regulation entitled, comact the Office of Comphalled as (21) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisa.http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rlurde

Miriam C. Provost, Ph.D. 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 Tak™ Family

Indications for Use:

Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder:
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal 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
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

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

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

(Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, and Neurological Devices

510(k) Number K050749

1 2

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.