# K043145: BI-Cortical Bio-Post and Washer, Model AR-1367B

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Feb 18, 2005 after 95 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K792022 (1979). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023119: BI-Cortical Bio Post and Washer, Model AR-1367B, Arthrex, Inc. (2002) Summary page 1.
- K011495: Arthrex Bio-Post and Washer, Arthrex, Inc. (2001) Summary page 1.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K012001: Smartscrew, Bionx Implants, Ltd. (2001) Summary page 1.
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 1.

## Recalls of this device
- Aug 12, 2016 · Class III · Z-2918-2016: The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

## Indications for use
1) The Arthrex Bi-Cortical Bio-PostTM and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow 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, Reconstruction, Midfoot Reconstruction. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Hand/Wrist: Scaphaolunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, UlInar or Radial Collateral Ligament Reconstruction. 2) The Arthrex Bi-Cortical Bio-Post MT and Washers device is intended for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot. Fusions/fracture of Phalangeal, Metacarpal, and Carpal Wrist arthrodesis Fractures of Distal radius, Olecranon, Radial head, Humeral condylar, Cancellous Osteotomies Malleolus, Ankle fractures, Metatarsal Correction of hallux valgus

Source page: https://510kreport.com/device/K043145
Methodology: https://510kreport.com/methodology