# K190728: Arthrex SwiveLock Anchors

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Apr 17, 2019 after 27 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 91 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.
- K150768: JuggerKnot Soft Anchors, Biomet Manufacturing Corp (2015) Summary page 4.

## Most influential descendants
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (2021), 1 descendant of its own
- K242296: VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (2024), 0 descendants of its own

## Indications for use
The Arthrex SwiveLock 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: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of 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. Hip: Capsular repair, acetabular labral repair. Proximal Hamstring Repair (4/75-5.5 PEEK SwiveLock only).

Source page: https://510kreport.com/device/K190728
Methodology: https://510kreport.com/methodology