510(k) · Cleared
ClearedTotal Wrist Arthroplasty System (TWA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Nov 1, 2024 as substantially equivalent to K233574 (Skeletal Dynamics, 2024) after a 2-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Nov 1, 2024
- Review
- 2 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961051 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- 2 generations backK021859 Wrist ImplantAvanta Orthopaedics, Inc. · 2002
- 1 generation backK233574 Total Wrist Arthroplasty System (TWA)Skeletal Dynamics · 2024
- This deviceK243381 Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| −2 | K021859 | Wrist Implant | Avanta Orthopaedics, Inc. | 2002 | — |
| −1 | K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | 2024 | — |
| 0 (this device) | K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K233574 | Total Wrist Arthroplasty System (TWA)Summary page 5…-constrained cemented prosthesis Classification Number: 21 CFR §888.3800 Regulatory Class: Class II Product Code: JWJ Predicate Devices Total Wrist Arthroplasty System (K233574) Device Description The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four… | 2024 |
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 28 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
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. 2024, 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 Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243381: Total Wrist Arthroplasty System (TWA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243381
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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