510(k) Report

510(k) · Cleared

Cleared

KinematX Total Wrist Arthroplasty System

K191525510(k) TraditionalCleared Mar 4, 2020268-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

Extremity Medical, LLC · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Cleared on Mar 4, 2020 as substantially equivalent to K042032 (Biomet, Inc., 2004) and 2 other predicates after a 268-day review. Its family tree reaches back 5 generations to 1996.

Decided
Mar 4, 2020
Review
268 days
Class
Class II
Product code
JWJ
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K961051 (1996). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2003: 1 other ancestorK961051 · Universal Total Wrist System (Modification) · Kinetikos Medical, Inc. · 1996K020554 · Modification to Universal Total Wrist System · Kinetikos Medical, Inc. · 2002K030037 · Universal Total Wrist System · Kinetikos Medical, Inc. · 2003K042032 · Maestro Total Wrist · Biomet, Inc. · 2004K132250 · Integra Freedom Wrist Arthroplasty System · Integra LifeSciences Corporation · 2014199520002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K132250 · Integra Freedom Wrist Arthroplasty System · Integra LifeSciences Corporation · 2014K042032 · Maestro Total Wrist · Biomet, Inc. · 2004K030037 · Universal Total Wrist System · Kinetikos Medical, Inc. · 2003K020554 · Modification to Universal Total Wrist System · Kinetikos Medical, Inc. · 2002K961051 · Universal Total Wrist System (Modification) · Kinetikos Medical, Inc. · 1996−50
  1. Root · 5 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
  2. 4 generations backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
  3. 3 generations backK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
  4. 2 generations backK042032 Maestro Total WristBiomet, Inc. · 2004
  5. 1 generation backK132250 Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014
  6. This deviceK191525 KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K961051Universal Total Wrist System (Modification)Kinetikos Medical, Inc.1996—
−4K020554Modification to Universal Total Wrist SystemKinetikos Medical, Inc.2002—
−3K030037Universal Total Wrist SystemKinetikos Medical, Inc.2003—
−2K042032Maestro Total WristBiomet, Inc.2004—
−1K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation2014—
0 (this device)K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
FIG. 1 — Lineage of K191525, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233574 Total Wrist Arthroplasty System (TWA)score 10.9 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K042032Maestro Total Wrist
Summary page 4
…etal/polymer semi-constrained cemented prosthesis Name and Number Product Code JWJ Common Name Total Wrist Replacement Device K042032, Maestro Total Wrist, Biomet, Inc. Predicate Devices K132250, Freedom Wrist Arthroplasty System, Integra Life Sciences Corpor…
Biomet, Inc.2004—
*K132250Integra Freedom Wrist Arthroplasty System
Summary page 4
…Product Code JWJ Common Name Total Wrist Replacement Device K042032, Maestro Total Wrist, Biomet, Inc. Predicate Devices K132250, Freedom Wrist Arthroplasty System, Integra Life Sciences Corporation K021859, Remotion Total Wrist, Stryke…
Integra LifeSciences Corporation2014—
*K021859Wrist Implant
Summary page 4
…K042032, Maestro Total Wrist, Biomet, Inc. Predicate Devices K132250, Freedom Wrist Arthroplasty System, Integra Life Sciences Corporation K021859, Remotion Total Wrist, Stryker The KinematX Total Wrist Arthroplasty System is a semi-constrained implant…
Avanta Orthopaedics, Inc.2002—

Also cleared against K042032: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
  • None of the 7 ancestors has a recall.
  • 4 other devices also cite its predicate K042032.

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. 2020, this device’s year, is highlighted.

FDA decisions per year · JWJ

3in 2024

2008: 12014: 12020: 22024: 3
2007high 3 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWJ

196in 2024

2024: 196 days median
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

2008: 12009: 42010: 52011: 42012: 72013: 92014: 112015: 72016: 482017: 372018: 312019: 1272020: 342021: 82022: 652023: 262024: 182025: 8
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—01
20090—04
20100—05
20110—04
20120—07
20130—09
20141—011
20150—07
20160—048
20170—037
20180—031
20190—0127
20202—034
20210—08
20220—065
20230—026
20243196018
20250—08
20260—0—

What is it indicated for?

The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain,

deformity, and/or limited motion caused by:

1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis,

and Kienbock's disease

2. Revision where other devices or treatments have failed

3. Scapholunate Advanced Collapse (SLAC)

4. Rheumatoid Arthritis

The device is intended to be implanted with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K042032

4 other devices cite the same predicate.

  • K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
  • K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014
  • K080426Maestro Wrist Fracture ImplantBiomet Manufacturing Corp · 2008
  • K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005

More from Extremity Medical, LLC

28 FDA decisions under this applicant name. See the company

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  • K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
  • K211261Axis Charcot Fixation SystemExtremity Medical, LLC · 2021

Recent decisions in JWJ

The JWJ category page

  • K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. · 2024
  • K233574Total Wrist Arthroplasty System (TWA)Skeletal Dynamics · 2024
  • K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
  • K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
  • K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014

https://510kreport.com/device/K191525 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191525: KinematX Total Wrist Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191525

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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