510(k) · Cleared
ClearedWrist Hemiarthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · KWN Prosthesis, Wrist, Carpal Lunate
Cleared on Dec 23, 2014 as substantially equivalent to K050028 (Biomet Manufacturing, Inc., 2005) after a 160-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Dec 23, 2014
- Review
- 160 days
- Class
- Class II
- Product code
- KWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961051 (1996). 8 ancestors in all, the oldest K864490 (1987). 1 later device descends from it, 1 citing it directly.
- 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 deviceK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK200718 Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020 · cites it directly0descendants
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) | K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014 | — |
| +1 | K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020 | — |
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 |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K050028 | Maestro Carpal HemiarthroplastySummary page 5…quivalent in indications and design principles to the following predicate device, which has been previously cleared by the FDA: Biomet Maestro Carpal Hemi-Arthroplasty (K050028, Cleared on 07/07/08) The fundamental scientific technology of the proposed device has not changed relative to the predicate dev… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | 2020 | 0 |
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 18 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.
- Of its descendants, K200718 (Arthrosurface, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050028.
How does its category compare?
All KWN devicesKWN Prosthesis, Wrist, Carpal Lunate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by:
Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
Rheumatoid arthritis
Revision where other devices or treatments have failed
Scapholunate Advanced Collapse (SLAC) and other functional deformities
Trauma, including fractures of the carpal bones
The device is a single use implant intended to be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141920: Wrist Hemiarthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141920
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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