# K000506: Bio-Fastak Suture Anchor, Model AR-1324B

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 1, 2000 after 76 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
No predicates in its family tree.
186 later devices descend from it; 3 cite it directly.
0 of 187 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
- K051219: Pushlock (2005), 151 descendants of its own
- K073509: Twinfix PK FP Suture Anchor (2008), 64 descendants of its own
- K061349: Opus Labralock P Knotless Fixation Device (2006), 50 descendants of its own
- K093428: Smith & Nephew Knotless Instability Anchor (2009), 41 descendants of its own
- K070882: Stryker Peek Twinloop Tac (2007), 35 descendants of its own

## Indications for use
The Bio-Fastak is intended for fixation of suture to bone. This product is intended for the following indications: 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, Midfoot Reconstruction, Metatarsal Ligament Repair 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Source page: https://510kreport.com/device/K000506
Methodology: https://510kreport.com/methodology