510(k) · Cleared

Cleared

Modification to Universal Total Wrist System

K020554510(k) SpecialCleared May 3, 200272-day reviewClass II21 CFR 888.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kinetikos Medical, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Cleared on May 3, 2002 as substantially equivalent to K961051 (Kinetikos Medical, Inc., 1996) after a 72-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it.

Decided: May 3, 2002
Review: 72 days
Class: Class II
Product code: JWJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K961051 (1996). 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
This deviceK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
Descendant · cites it directly · 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 · 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

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all

K031203Biax a.F. Wrist/Biax Advanced Fixation WristDePuy Orthopaedics, Inc. · 2003 · cites it directly8descendants
K030037Universal Total Wrist SystemKinetikos Medical, Inc. · 2003 · cites it directly8descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961051	Universal Total Wrist System (Modification)	Kinetikos Medical, Inc.	1996	—
0 (this device)	K020554	Modification to Universal Total Wrist System	Kinetikos Medical, Inc.	2002	—
+1	K031203	Biax a.F. Wrist/Biax Advanced Fixation Wrist	DePuy Orthopaedics, Inc.	2003	—
+1	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	—
+2	K132250	Integra Freedom Wrist Arthroplasty System	Integra LifeSciences Corporation	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	1	0
2008	1	0
2014	2	0
2020	2	0
2024	1	0

FIG. 1 — Lineage of K020554, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K961051	Universal Total Wrist System (Modification) Summary page 1 …ATE DEVICE INFORMATION The principal predicate device for this modification is the Kinetikos Medical Universal Total Wrist™ System, cleared by FDA on June 6, 1996 under K961051. PACKAGING/LABELING/PRODUCT INFORMATION Packaging and labeling of the device will be the same as that of the present Universal…	Kinetikos Medical, Inc.	1996	—

Also cleared against K961051: 2 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031203	Biax a.F. Wrist/Biax Advanced Fixation Wrist	DePuy Orthopaedics, Inc.	2003	8
K030037	Universal Total Wrist System	Kinetikos Medical, Inc.	2003	8
K042032	Maestro Total Wrist	Biomet, Inc.	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?

Its one ancestor has no recall.
Of its descendants, K031203 (DePuy Orthopaedics, Inc., 2003) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K961051.

How does its category compare?

All JWJ devices

JWJ 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

2007high 3 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWJ

196in 2024

2007high 196 (2024)2026

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

2007high 127 (2019) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	1	—	1
2009	0	—	4
2010	0	—	5
2011	0	—	4
2012	0	—	7
2013	0	—	9
2014	1	—	11
2015	0	—	7
2016	0	—	48
2017	0	—	37
2018	0	—	31
2019	0	—	127
2020	2	—	34
2021	0	—	8
2022	0	—	65
2023	0	—	26
2024	3	196	18
2025	0	—	8
2026	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. Intended for cemented use only.

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/K020554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020554: Modification to 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/K020554

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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