# K020043: 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw, Models AR-1555B

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 2, 2002 after 85 days
- Product code: HWC (Screw, Fixation, Bone)
- 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
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103831: Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 (2011), 18 descendants of its own
- K112249: Healix Knotless (TM) Anchor (2011), 13 descendants of its own
- K130917: Healix Advance Knotless BR Anchor (2013), 9 descendants of its own
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) (2013), 4 descendants of its own
- K131974: Healix Advance Knotless BR Anchor (6.5MM) (2013), 3 descendants of its own

## Indications for use
The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically; 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, Midfoot Reconstruction, Metatarsal Ligament Repair Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K020043
Methodology: https://510kreport.com/methodology