# K150648: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 20, 2015 after 161 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: 7 generations back to K961555 (1996). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 5.
- K112237: Microsuture Anchors, Arthrex, Inc. (2011) Summary page 5.

## Most influential descendants
- K252664: GMReis Suture Anchors (2025), 1 descendant of its own
- K251750: Trax EX Anchor (2026), 0 descendants of its own
- K254188: Meniscus Versaflex (2026), 0 descendants of its own
- K253895: Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (2025), 0 descendants of its own

## Indications for use
The Arthrex MicroSuture Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications for use are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendous at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty) Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis 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 Repairs, 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/K150648
Methodology: https://510kreport.com/methodology