# K203495: Arthrex SwiveLock Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 19, 2021 after 143 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K792022 (1979). 91 ancestors in all.
13 later devices descend from it; 11 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191226: Arthrex SwiveLock Suture Anchor, Arthrex, Inc. (2019) Summary page 5.
- K201749: Arthrex SwiveLock Anchor, Arthrex, Inc. (2020) Summary page 5.

## Most influential descendants
- 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
- K260405: FiberTape Button (2026), 0 descendants of its own

## Recalls of this device
- Jun 14, 2021 · Class II · Z-2107-2021: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

## 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: 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, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only) 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, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).

Source page: https://510kreport.com/device/K203495
Methodology: https://510kreport.com/methodology