# K151342: Arthrex SwiveLock Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 24, 2016 after 310 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971358 (1997). 29 ancestors in all.
38 later devices descend from it; 5 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 4.
- K071176: Modification to: Arthrex Interference Screw, Arthrex, Inc. (2007) Summary page 4.

## Most influential descendants
- K171141: Arthrex SwiveLock Anchors (2017), 29 descendants of its own
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own
- K191226: Arthrex SwiveLock Suture Anchor (2019), 21 descendants of its own
- K203495: Arthrex SwiveLock Anchor (2021), 13 descendants of its own
- K173845: Arthrex SwiveLock (2018), 8 descendants of its own

## Indications for use
The Arthrex SwiveLock anchors 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 and Bunionectomy. * Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 — 5.5 SwiveLock only). * Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. * Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. * Hip: Capsular repair, acetabular labral repair

Source page: https://510kreport.com/device/K151342
Methodology: https://510kreport.com/methodology