510(k) · Cleared
ClearedIntegra Freedom Wrist Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Mar 24, 2014 as substantially equivalent to K030037 (Kinetikos Medical, Inc., 2003) and 1 other predicate after a 248-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 24, 2014
- Review
- 248 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961051 (1996). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK961051 Universal Total Wrist System (Modification)Kinetikos Medical, Inc. · 1996
- 3 generations backK020554 Modification to Universal Total Wrist SystemKinetikos Medical, Inc. · 2002
- 2 generations backK030037 Universal Total Wrist SystemKinetikos Medical, Inc. · 2003
- 1 generation backK042032 Maestro Total WristBiomet, Inc. · 2004
- This deviceK132250 Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation · 2014
- Descendant · cites it directly · 0 of its ownK233674 Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK191525 KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961051 | Universal Total Wrist System (Modification) | Kinetikos Medical, Inc. | 1996 | — |
| −3 | K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | 2002 | — |
| −2 | K030037 | Universal Total Wrist System | Kinetikos Medical, Inc. | 2003 | — |
| −1 | K042032 | Maestro Total Wrist | Biomet, Inc. | 2004 | — |
| 0 (this device) | K132250 | Integra Freedom Wrist Arthroplasty System | Integra LifeSciences Corporation | 2014 | — |
| +1 | K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 2024 | — |
| +1 | K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K030037 | Universal Total Wrist SystemSummary page 1…Class 11, under 2I1CFR §888.3800 Product Code JWJ 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed * Universal Total Wrist System (K03003 7), cleared February 05, 2003 * MaestroTM Total Wrist (K042032), cleared October 7, 2004 807.92(a)(4) - Device description The INTE… | 2003 |
| * | K042032 | Maestro Total WristSummary page 1…J 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed * Universal Total Wrist System (K03003 7), cleared February 05, 2003 * MaestroTM Total Wrist (K042032), cleared October 7, 2004 807.92(a)(4) - Device description The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-… | 2004 |
What descends from it? (2)
2 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K233674 (Ascension Orthopedics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030037.
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. 2014, 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 INTEGRA®D Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace fuinctionality of the joint due to deformity or elements stated above. The INTEGRA& Freedom Wrist Arthroplasty System is intended for cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132250: Integra Freedom Wrist Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132250
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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