# K101823: Arthrex Swivelock Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 7, 2011 after 191 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 8 ancestors in all.
103 later devices descend from it; 14 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew, Arthrex, Inc. (2009) Summary page 1.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 1.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 1.

## Most influential descendants
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) (2011), 40 descendants of its own
- K151342: Arthrex SwiveLock Anchors (2016), 38 descendants of its own
- K171141: Arthrex SwiveLock Anchors (2017), 29 descendants of its own
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own
- K133671: Iconix All Suture Anchors (2014), 25 descendants of its own

## Recalls of this device
- Mar 24, 2017 · Class II · Z-2041-2017: Some eyelets broke from SwiveLock Anchor on insertion.
- Mar 24, 2017 · Class II · Z-2043-2017: Some eyelets broke from SwiveLock Anchor on insertion.
- Mar 24, 2017 · Class II · Z-2044-2017: Some eyelets broke from SwiveLock Anchor on insertion.
- Mar 24, 2017 · Class II · Z-2042-2017: Some eyelets broke from SwiveLock Anchor on insertion.
- Mar 24, 2017 · Class II · Z-2046-2017: Some eyelets broke from SwiveLock Anchor on insertion.
- Mar 24, 2017 · Class II · Z-2045-2017: Some eyelets broke from SwiveLock Anchor on insertion.

## 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 Repairs, 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. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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/K101823
Methodology: https://510kreport.com/methodology