510(k) · Cleared
ClearedWrist Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanta Orthopaedics, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Dec 2, 2002 as substantially equivalent to K961051 (Kinetikos Medical, Inc., 1996) after a 179-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Dec 2, 2002
- Review
- 179 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961051 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- This deviceK021859 Wrist ImplantAvanta Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK233574 Total Wrist Arthroplasty System (TWA)Skeletal Dynamics · 2024
- Descendant · 2 generations on · 0 of its ownK243381 Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK200718 Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK191525 KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K233574Total Wrist Arthroplasty System (TWA)Skeletal Dynamics · 2024 · cites it directly1descendant
- K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. · 2024 · 2 generations on0descendants
- K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020 · cites it directly0descendants
- K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| 0 (this device) | K021859 | Wrist Implant | Avanta Orthopaedics, Inc. | 2002 | — |
| +1 | K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | 2024 | — |
| +2 | K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | 2024 | — |
| +1 | K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020 | — |
| +1 | K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K961051 | Universal Total Wrist System (Modification)Summary page 1…JWJ Predicate Device: Universal Total Wrist System, KMI, K961051 Registration Number: 2030506 Owner Operator Number: 9001389 Device Descriptio… | 1996 |
What descends from it? (4)
3 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?
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.
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?
Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021859 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021859: Wrist Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021859
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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