510(k) · Cleared
ClearedFreedom Wrist Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on May 30, 2024 as substantially equivalent to K132250 (Integra LifeSciences Corporation, 2014) after a 196-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- May 30, 2024
- Review
- 196 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961051 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK132250 Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014
- This deviceK233674 Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
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 | K132250 | Integra Freedom Wrist Arthroplasty System | Integra LifeSciences Corporation | 2014 | — |
| 0 (this device) | K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K132250 | Integra Freedom Wrist Arthroplasty SystemSummary page 4…-Metal Articulation, Semi-Confi | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132250 Integra Freedom Wrist Arthroplasty System JWJ Device Description Summary 21 CFR 807.92(a)(4) The Freedom Wrist Arthroplasty Syst… | 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 28 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K132250.
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 Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.
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/K233674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233674: Freedom Wrist Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233674
Report an extraction error
Are you the manufacturer?
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