# K201749: Arthrex SwiveLock Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 21, 2020 after 56 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: 8 generations back to K961555 (1996). 10 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192532: Arthrex SwiveLock Anchor, Arthrex, Inc. (2019) Summary page 4.

## Most influential descendants
- K203495: Arthrex SwiveLock Anchor (2021), 13 descendants of its own
- K243712: WasherCap™ Mini Fixation System (Model 45) (2025), 1 descendant of its own
- K233893: AlphaVent Knotless SP PEEK Anchor (2024), 1 descendant of its own
- K230435: Arthrex 3.9 mm SwiveLock Anchor (2023), 1 descendant of its own
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (2021), 1 descendant of its own

## Indications for use
The Arthrex SwiveLock Anchor is 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 and MPFL Repair/Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair 7HQQLV (OERZ • Hip: Capsular Repair, Acetabular labral repair

Source page: https://510kreport.com/device/K201749
Methodology: https://510kreport.com/methodology