The Arthrex PushLock™ 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:

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

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 PushLock™ (suture anchor) is a 2 piece "push-in" anchor. The suture anchor is designed to use the principles of compression to force the eyelet, threaded with appropriate suture, into a predrilled hole.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, or any studies with specific details like sample sizes, expert qualifications, or ground truth establishment. The document is primarily a 510(k) summary for the Arthrex 2.5 mm PushLock™, focusing on its substantial equivalence to a predicate device and its intended uses.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based only on the provided input.

The document states:

Substantial Equivalence Summary: "The Arthrex PushLock™ (suture anchor) is substantially equivalent to the predicate Arthrex Tak Family in which the basic features and intended uses are the same. Any differences between the PushLock™ (suture anchor) and the predicate Tak Family are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new PushLock™ (suture anchor) is substantially equivalent to the currently marketed predicate device."

This indicates that the primary "proof" for market clearance in this 510(k) was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than through a de novo study with explicit acceptance criteria and performance metrics. The FDA has made a substantial equivalence determination.

To answer your questions, I would need additional documentation, such as performance testing reports, clinical data summaries, or detailed bench testing results, which are not present in this 510(k) summary.

Summary

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Ko63479 page '14

VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ARTHREX 2.5 MM PUSHLOCK™

DEC 1 3 2006

Manufacturer / Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945
510(K) Contact	Ann Waterhouse, RACRegulatory Affairs Project ManagerTelephone: (239) 643-5553 ext. 1179FAX: (239) 598-5539
Trade Name	PushLock™
Common Name	Fastener; Screw, Fixation, Bone
Product Code/Classification Name	HWC/MBI 21 CFR 888.3040Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallicbone fixation fastenerMAI/ 21 CFR 888.3030Fastener, Fixation, Biodegradable, SoftTissue
Predicate Device	Tak Family Suture Anchors: K050749

Device Description and Intended Use

The Arthrex PushLock™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications.

Substantial Equivalence Summary

The Arthrex PushLock™ (suture anchor) is substantially equivalent to the predicate Arthrex Tak Family in which the basic features and intended uses are the same. Any differences between the PushLock™ (suture anchor) and the predicate Tak Family are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new PushLock™ (suture anchor) is substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

DEC 1 3 2006

Re: K063479

Trade/Device Name: Arthrex 2.5mm PushLock™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: November 16, 2006 Received: November 22, 2006

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) 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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Indications for Use Form ==============================================================================================================================================================================

510(k) Number (if known): K063479

Device Name: Arthrex 2.5 mm PushLock™

Indications for Use:

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

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, 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

Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) Company of Children Comments (21 CFR 801 Subpart C)

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

============================================================================================================================================================================== The Collection, Office of Device Evaluation (ODE) (NUND)

ion-( ) if Division of General, Restorative, and Newslogical Devices

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510(k) Number Ko63479

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.