# K192441: Arthrex SwiveLock Anchors

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Oct 17, 2019 after 41 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: 10 generations back to K792022 (1979). 89 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173845: Arthrex SwiveLock, Arthrex, Inc. (2018) Summary page 4.
- K180768: Arthrex SwiveLock Anchors, Arthrex, Inc. (2018) Summary page 4.

## Most influential descendants
- K251309: OSSIOfiber® Suture Anchor (2025), 1 descendant of its own
- K254055: OSSIOfiber® Suture Anchor (2026), 0 descendants of its own

## Indications for use
The Arthrex SwiveLock Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures: * Shoulder: Rotator Cuff Repairs, 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, Quadriceps Tendon Repair and Meniscal root repair (4.75 SwiveLock C only). 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, 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/K192441
Methodology: https://510kreport.com/methodology