# K031203: Biax a.F. Wrist/Biax Advanced Fixation Wrist

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 14, 2003 after 89 days
- Product code: JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961051 (1996). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020554: Modification to Universal Total Wrist System, Kinetikos Medical, Inc. (2002)

## Cited in the summary but kept off the family tree
- K842266: DePuy Biax Wrist (Formerly called “Beckenbaugh Wrist Prosthesis”). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K042032: Maestro Total Wrist (2004), 7 descendants of its own
- K050028: Maestro Carpal Hemiarthroplasty (2005), 3 descendants of its own
- K132250: Integra Freedom Wrist Arthroplasty System (2014), 2 descendants of its own
- K141920: Wrist Hemiarthroplasty System (2014), 1 descendant of its own
- K233674: Freedom Wrist Arthroplasty System (2024), 0 descendants of its own

## Indications for use
The DePuy Biax A.F. Wrist System is intended to give patients limited wrist mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the wrist joint. The DePuy Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity andor limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction The DePuy Biax A.F. Wrist System is also indicated for revision of' a failed previous wrist surgery. CAUTION: The DePuy Biax A.F. Wrist System is for cemented use only.

Source page: https://510kreport.com/device/K031203
Methodology: https://510kreport.com/methodology