510(k) · Cleared
ClearedMaestro Wrist Fracture Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Jul 29, 2008 as substantially equivalent to K042032 (Biomet, Inc., 2004) and 1 other predicate after a 160-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 29, 2008
- Review
- 160 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961051 (1996). 8 ancestors in all, the oldest K864490 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- 4 generations backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
- 3 generations backK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
- 2 generations backK042032 Maestro Total WristBiomet, Inc. · 2004
- 1 generation backK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
- This deviceK080426 Maestro Wrist Fracture ImplantBiomet Manufacturing Corp · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| −4 | K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | 2002 | — |
| −3 | K030037 | Universal Total Wrist System | Kinetikos Medical, Inc. | 2003 | — |
| −2 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| −1 | K050028 | Maestro Carpal Hemiarthroplasty | Biomet Manufacturing, Inc. | 2005 | — |
| 0 (this device) | K080426 | Maestro Wrist Fracture Implant | Biomet Manufacturing Corp | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K042032 | Maestro Total WristSummary page 1…er semi-constrained cemented prosthesis (21 CFR 888.3800) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: : Maestro TM Total Wrist System, 510(k) K042032 * Maestro TM Carpal HemiArthroplasty, 510(k) K050028 Device Description: The Maestro TM Wrist Fracture Replacement System cons… | 2004 |
| * | K050028 | Maestro Carpal HemiarthroplastySummary page 1…0) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: : Maestro TM Total Wrist System, 510(k) K042032 * Maestro TM Carpal HemiArthroplasty, 510(k) K050028 Device Description: The Maestro TM Wrist Fracture Replacement System consists of a two piece radial component and a molded carpa… | 2005 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- 4 other devices also cite its predicate K042032.
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. 2008, this device’s year, is highlighted.
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 Maestro TM 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 (SLAG) and other functional deformities.
5) Trauma, including fractures of the distal radius and/or carpal bones.
The radial and carpal components are intended to be implanted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080426: Maestro Wrist Fracture Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080426
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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