510(k) Report

510(k) · Cleared

Cleared

Maestro Total Wrist

K042032510(k) TraditionalCleared Oct 7, 200471-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

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

Cleared on Oct 7, 2004 as substantially equivalent to K031203 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.

Decided
Oct 7, 2004
Review
71 days
Class
Class II
Product code
JWJ
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K961051 (1996). 4 ancestors in all. 7 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2008: 1 descendant cleared2005: 1 descendant cleared2020: 2 descendants cleared2014: 2 descendants cleared2024: 1 descendant clearedK961051 · 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. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 2 descendants K030037 · 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. · 19960
  1. Root · 3 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
  2. 2 generations backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
  3. 1 generation backK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
  4. This deviceK042032 Maestro Total WristBiomet, Inc. · 2004
  5. Descendant · cites it directly · 3 of its ownK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
  6. Descendant · cites it directly · 2 of its ownK132250 Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014
  7. Descendant · 2 generations on · 1 of its ownK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
  8. Descendant · 2 generations on · 0 of its ownK233674 Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
  9. Descendant · cites it directly · 0 of its ownK200718 Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12014: 22020: 22024: 1
2005high 2 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005 · cites it directly3descendants
  • K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014 · cites it directly2descendants
  • K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014 · 2 generations on1descendant
  • K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024 · 2 generations on0descendants
  • K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961051Universal Total Wrist System (Modification)Kinetikos Medical, Inc.1996—
−2K020554Modification to Universal Total Wrist SystemKinetikos Medical, Inc.2002—
−1K030037Universal Total Wrist SystemKinetikos Medical, Inc.2003—
0 (this device)K042032Maestro Total WristBiomet, Inc.2004—
+1K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc.2005—
+1K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation2014—
+2K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc.2014—
+2K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.2024—
+1K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201420
202020
202410
FIG. 1 — Lineage of K042032, 1996–2024Source: 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
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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
*K031203Biax a.F. Wrist/Biax Advanced Fixation Wrist
Summary page 1
…cemented prosthesis (21 CFR 888.3800) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: BiaXTm A.F. Wrist System (DePuy Orthopedics, Inc.) - K031203 Universal2® Total Wrist System (Kineitkos medical) - K020554 & K030037…
DePuy Orthopaedics, Inc.2003—
*K020554Modification to Universal Total Wrist System
Summary page 1
…Which Substantial Equivalence Is Claimed: BiaXTm A.F. Wrist System (DePuy Orthopedics, Inc.) - K031203 Universal2® Total Wrist System (Kineitkos medical) - K020554 & K030037 two piece Device Description: The MaestroTm To…
Kinetikos Medical, Inc.2002—
*K030037Universal Total Wrist System
Summary page 1
…tantial Equivalence Is Claimed: BiaXTm A.F. Wrist System (DePuy Orthopedics, Inc.) - K031203 Universal2® Total Wrist System (Kineitkos medical) - K020554 & K030037 two piece Device Description: The MaestroTm Total Wrist…
Kinetikos Medical, Inc.2003—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc.20053
K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation20142
K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.20200
K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC20200
K080426Maestro Wrist Fracture ImplantBiomet Manufacturing Corp20080

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 8 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K050028 (Biomet Manufacturing, Inc., 2005) has gone furthest, with 3 descendants of its own.

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

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 MaestroTM Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:

1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis

2) Rheumatoid arthritis

3) Revision where other devices or treatments have failed

4) Scapholunate Advanced Collapse (SLAC) and other functional deformities

5) Trauma, including fractures of the distal radius and/or carpal bones

The device is intended to be implanted with bone cement.

Indications for use as stated in the FDA summary.

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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
  • K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC · 2020

https://510kreport.com/device/K042032 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042032: Maestro Total Wrist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042032

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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