# K251145: Arthrex PushLock Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 10, 2025 after 87 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K961555 (1996). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 6.
- K063479: Arthrex Pushlock, Arthrex, Inc. (2006) Summary page 6.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 6.
- K151092: Arthrex Short Suture Anchors, Arthrex, Inc. (2016) Summary page 6.
- K221099: Arthrex Self-Punching PushLock Suture Anchor, Arthrex, Inc. (2022) Summary page 6.

## Most influential descendants
- K252664: GMReis Suture Anchors (2025), 1 descendant of its own
- K254188: Meniscus Versaflex (2026), 0 descendants of its own

## Indications for use
The Arthrex PushLock Suture Anchors (2.9 - 4.5 mm) are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, UInar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair (2.9 x 15.5 - 24 mm only), acetabular labral repair. The Arthrex PushLock Suture Anchors (2.5 mm) are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below: 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 The Arthrex Short Suture Anchors (2.0 - 2.4 mm) are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair. The Arthrex Self-Punching PushLock Suture Anchors (3.5 mm) are intended to be used for suture (soft tissue) fixation to bone in the shoulder: Shoulder: Rotator Cuff Repair

Source page: https://510kreport.com/device/K251145
Methodology: https://510kreport.com/methodology