510(k) · Cleared
ClearedBiax a.F. Wrist/Biax Advanced Fixation Wrist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Jul 14, 2003 as substantially equivalent to K020554 (Kinetikos Medical, Inc., 2002) after an 89-day review. Its family tree reaches back 2 generations to 1996. 8 later devices descend from it.
- Decided
- Jul 14, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961051 (1996). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- 1 generation backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
- This deviceK031203 Biax a.F. Wrist/Biax Advanced Fixation WristDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK042032 Maestro Total WristBiomet, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK132250 Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014
- Descendant · 3 generations on · 1 of its ownK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK233674 Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K042032Maestro Total WristBiomet, Inc. · 2004 · cites it directly7descendants
- K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005 · 2 generations on3descendants
- K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014 · 2 generations on2descendants
- K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014 · 3 generations on1descendant
- K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| −1 | K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | 2002 | — |
| 0 (this device) | K031203 | Biax a.F. Wrist/Biax Advanced Fixation Wrist | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| +2 | K050028 | Maestro Carpal Hemiarthroplasty | Biomet Manufacturing, Inc. | 2005 | — |
| +2 | K132250 | Integra Freedom Wrist Arthroplasty System | Integra LifeSciences Corporation | 2014 | — |
| +3 | K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014 | — |
| +3 | K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2020 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWJ device
- #1 K233574 Total Wrist Arthroplasty System (TWA)score 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…ederal Food, Drug, and Cosmetic Act for a wrist prosthesis. Substantially Equivalent Devices: DePuy Biax Wrist IC842266 (Formerly called “Beckenbaugh Wrist Prosthesis”) Kinetikos Un… | |
| * | K020554 | Modification to Universal Total Wrist System | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042032 | Maestro Total Wrist | 2004 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042032 (Biomet, Inc., 2004) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K020554.
How does its category compare?
All JWJ devicesJWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWJ
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JWJ
196in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWJ
No recall names JWJ since 2007.
Adverse event reports per year · JWJ
8in 2025
MAUDE reports naming product code JWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 48 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 127 |
| 2020 | 2 | — | 0 | 34 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 65 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 3 | 196 | 0 | 18 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031203: Biax a.F. Wrist/Biax Advanced Fixation Wrist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031203
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026