510(k) · Cleared
ClearedUniversal Total Wrist System (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetikos Medical, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Jun 6, 1996 after an 87-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Jun 6, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
- Descendant · 2 generations on · 8 of its ownK031203 Biax a.F. Wrist/Biax Advanced Fixation WristDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
- Descendant · 2 generations on · 7 of its ownK042032 Maestro Total WristBiomet, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK021859 Wrist ImplantAvanta Orthopaedics, Inc. · 2002
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K020554Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002 · cites it directly10descendants
- K031203Biax a.F. Wrist/Biax Advanced Fixation WristDePuy Orthopaedics, Inc. · 2003 · 2 generations on8descendants
- K030037Universal Total Wrist SystemKinetikos Medical, Inc. · 2003 · cites it directly8descendants
- K042032Maestro Total WristBiomet, Inc. · 2004 · 2 generations on7descendants
- K021859Wrist ImplantAvanta Orthopaedics, Inc. · 2002 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| +1 | K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | 2002 | — |
| +2 | K031203 | Biax a.F. Wrist/Biax Advanced Fixation Wrist | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K030037 | Universal Total Wrist System | Kinetikos Medical, Inc. | 2003 | — |
| +2 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| +1 | K021859 | Wrist Implant | Avanta Orthopaedics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2020 | 2 | 0 |
| 2024 | 3 | 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Protek Meuli Wrist Named without a submission number | |
| * | — | Howmedica AMC Wrist Named without a submission number | |
| * | — | Depuy Bi-Axial Wrist Named without a submission number |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K020554 (Kinetikos Medical, Inc., 2002) has gone furthest, with 10 descendants of its own.
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 KMI Umiversal Total Wrist™ System is indicated for mtractable pam resulting from traumatic arthritis, osteo anhritis, rheumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to defonmity or elements stated above.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961051 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961051: Universal Total Wrist System (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961051
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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