510(k) · Cleared
ClearedMaestro Carpal Hemiarthroplasty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · KWN Prosthesis, Wrist, Carpal Lunate
Cleared on Mar 25, 2005 as substantially equivalent to K864490 (Dow Corning Wright, 1987) and 2 other predicates after a 78-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Mar 25, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- KWN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K961051 (1996). 7 ancestors in all, the oldest K864490 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- 3 generations backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
- 2 generations backK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
- 1 generation backK042032 Maestro Total WristBiomet, Inc. · 2004
- This deviceK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK200718 Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK080426 Maestro Wrist Fracture ImplantBiomet Manufacturing Corp · 2008
Most influential descendants
Showing 3 of 3 · See all- K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014 · cites it directly1descendant
- K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020 · 2 generations on0descendants
- K080426Maestro Wrist Fracture ImplantBiomet Manufacturing Corp · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| −3 | K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | 2002 | — |
| −2 | K030037 | Universal Total Wrist System | Kinetikos Medical, Inc. | 2003 | — |
| −1 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| 0 (this device) | K050028 | Maestro Carpal Hemiarthroplasty | Biomet Manufacturing, Inc. | 2005 | — |
| +1 | K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014 | — |
| +2 | K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 KWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K864490 | Swanson Titanium Carpal Scaphoid ImplantSummary page 1…ssification Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Swanson Titanium Carpal Scaphoid Implant (Wright Medical Technologies) - K864490 Swanson Titanium Carpal Lunate Implant (Wright Medical Technologies) - K864491 Maestro TM Total Wrist System… | 1987 |
| * | K864491 | Swanson Titanium Carpal Lunate ImplantSummary page 1…nson Titanium Carpal Scaphoid Implant (Wright Medical Technologies) - K864490 Swanson Titanium Carpal Lunate Implant (Wright Medical Technologies) - K864491 Maestro TM Total Wrist System (Biomet Manufacturing Corp.) - K042032 Device Description: The MaestroTM Carpal HemiArthrop… | 1987 |
| * | K042032 | Maestro Total WristSummary page 1…K864490 Swanson Titanium Carpal Lunate Implant (Wright Medical Technologies) - K864491 Maestro TM Total Wrist System (Biomet Manufacturing Corp.) - K042032 Device Description: The MaestroTM Carpal HemiArthroplasty is a three piece carpal component designed to articulate with the natu… | 2004 |
What descends from it? (3)
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 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K141920 (Arthrosurface, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K864490.
How does its category compare?
All KWN devicesKWN Prosthesis, Wrist, Carpal Lunate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KWN
Too few KWN 510(k)s in any year since 2007 to give a median.
Recalls per year · KWN
No recall names KWN since 2007.
Adverse event reports per year · KWN
2in 2020
MAUDE reports naming product code KWN, 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 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MaestroTM Carpal HemiArthroplasty 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 carpal bones
The device is intended to be implanted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050028: Maestro Carpal Hemiarthroplasty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050028
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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