# K011495: Arthrex Bio-Post and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 1, 2001 after 78 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) Synthes Bioresorbable Suture Anchor: named in the summary without a submission number
- (no number) Smartwedge ACL: named in the summary without a submission number
- (no number) Smart Screw ACL: named in the summary without a submission number
- (no number) Biocuff: named in the summary without a submission number

## Most influential descendants
- K043145: BI-Cortical Bio-Post and Washer, Model AR-1367B (2005), 0 descendants of its own

## Indications for use
The Arthrex Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone. 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 VaIgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis Hand[Wrist: Scapholunate Ligament Reconstruction, UInar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K011495
Methodology: https://510kreport.com/methodology