# K191226: Arthrex SwiveLock Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jun 11, 2019 after 35 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). 88 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180768: Arthrex SwiveLock Anchors, Arthrex, Inc. (2018) Summary page 4.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 4.

## Most influential descendants
- K203495: Arthrex SwiveLock Anchor (2021), 13 descendants of its own
- K193503: Arthrex SwiveLock Suture Anchor (2020), 4 descendants of its own
- K213415: OSSIOfiber Suture Anchor (2022), 3 descendants of its own
- K251309: OSSIOfiber® Suture Anchor (2025), 1 descendant of its own
- K243712: WasherCap™ Mini Fixation System (Model 45) (2025), 1 descendant of its own

## Indications for use
The Arthrex SwiveLock Suture 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: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct 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/K191226
Methodology: https://510kreport.com/methodology