# K180768: Arthrex SwiveLock Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 14, 2018 after 266 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: 9 generations back to K792022 (1979). 87 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151342: Arthrex SwiveLock Anchors, Arthrex, Inc. (2016) Summary page 4.
- K171141: Arthrex SwiveLock Anchors, Arthrex, Inc. (2017) Summary page 4.
- K150768: JuggerKnot Soft Anchors, Biomet Manufacturing Corp (2015) Summary page 4.

## Most influential descendants
- K191226: Arthrex SwiveLock Suture Anchor (2019), 21 descendants of its own
- K203495: Arthrex SwiveLock Anchor (2021), 13 descendants of its own
- K232973: Arthrex Knee FiberTak® Button Suture Anchor (2023), 4 descendants of its own
- K193503: Arthrex SwiveLock Suture Anchor (2020), 4 descendants of its own
- K241235: Arthrex TightRope II (2024), 3 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, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair.

Source page: https://510kreport.com/device/K180768
Methodology: https://510kreport.com/methodology