510(k) · Cleared
ClearedArthrosurface WristMotion Total Wrist Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Oct 15, 2020 as substantially equivalent to K021859 (Avanta Orthopaedics, Inc., 2002) and 2 other predicates after a 210-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 15, 2020
- Review
- 210 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961051 (1996). 10 ancestors in all, the oldest K864490 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- 5 generations backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
- 4 generations backK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
- 3 generations backK042032 Maestro Total WristBiomet, Inc. · 2004
- 2 generations backK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
- 1 generation backK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
- This deviceK200718 Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| −5 | K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | 2002 | — |
| −4 | K030037 | Universal Total Wrist System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| −2 | K050028 | Maestro Carpal Hemiarthroplasty | Biomet Manufacturing, Inc. | 2005 | — |
| −1 | K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014 | — |
| 0 (this device) | 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 |
| 2002 | 1 | 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? (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 |
|---|---|---|---|
| * | K021859 | Wrist ImplantSummary page 5…principles to the following predicate devices, which have been previously cleared by the FDA: Primary Predicate Avanta Orthopaedics Inc. Total Wrist (K021859) Now Stryker ReMotion Reference Predicate Devices Biomet Maestro Total Wrist Syste… | 2002 |
| * | K042032 | Maestro Total WristSummary page 5…rthopaedics Inc. Total Wrist (K021859) Now Stryker ReMotion Reference Predicate Devices Biomet Maestro Total Wrist System (K042032) Arthrosurface HemiCAP Wrist (K141920) The fundamental scientific technology of the propose… | 2004 |
| * | K141920 | Wrist Hemiarthroplasty SystemSummary page 5…Now Stryker ReMotion Reference Predicate Devices Biomet Maestro Total Wrist System (K042032) Arthrosurface HemiCAP Wrist (K141920) The fundamental scientific technology of the proposed device has not changed relative to the predicate device. • Total ar… | 2014 |
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 5.8 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K021859.
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. 2020, 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 Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
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/K200718 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200718: Arthrosurface WristMotion Total Wrist Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200718
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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