510(k) · Cleared
ClearedUniversal Total Wrist System
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 Feb 5, 2003 as substantially equivalent to K961051 (Kinetikos Medical, Inc., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1996. 8 later devices descend from it.
- Decided
- Feb 5, 2003
- Review
- 30 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, 2 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 deviceK030037 Universal Total Wrist SystemKinetikos Medical, 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 · cites it directly · 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 · 2 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 · cites it directly2descendants
- K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014 · 3 generations on1descendant
- K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024 · 2 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) | K030037 | Universal Total Wrist System | Kinetikos Medical, Inc. | 2003 | — |
| +1 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| +2 | K050028 | Maestro Carpal Hemiarthroplasty | Biomet Manufacturing, Inc. | 2005 | — |
| +1 | K132250 | Integra Freedom Wrist Arthroplasty System | Integra LifeSciences Corporation | 2014 | — |
| +3 | K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014 | — |
| +2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961051 | Universal Total Wrist System (Modification)Summary page 1…e device for this modification is the Kinetikos Medical Universal Total Wrist System -sizes Small, Medium and Large- originally cleared b y FDA on June 6, 1996 u n d e r K961051, and modified system version cleared May 03, 2002 under K020554. PACKAGING/LABELING/PRODUCT INFORMATION Packaging and labeling… | 1996 |
| * | K020554 | Modification to Universal Total Wrist SystemSummary page 1…l Total Wrist System -sizes Small, Medium and Large- originally cleared b y FDA on June 6, 1996 u n d e r K961051, and modified system version cleared May 03, 2002 under K020554. PACKAGING/LABELING/PRODUCT INFORMATION Packaging and labeling of the device will be the same as that of the predicate Universa… | 2002 |
What descends from it? (8)
2 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?
- The line of descent spans 7 years and passes through 1 company; 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 K961051.
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?
Indicated for intractable pain resulting from traumatic arthritis, osteoarthritis,
rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To
replace functionality of the joint due to deformity or elements stated above.
The Universal Total Wrist is intended for cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030037: Universal Total Wrist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030037
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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