# K230435: Arthrex 3.9 mm SwiveLock Anchor

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 17, 2023 after 28 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: 12 generations back to K792022 (1979). 92 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 94 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.
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 4.

## Most influential descendants
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants 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 skeletally mature pediatric and adult patients for the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, and MPFL Repair Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair Hip: Capsular Repair and Acetabular labral repair

Source page: https://510kreport.com/device/K230435
Methodology: https://510kreport.com/methodology