510(k) · Cleared
ClearedFreedom Total Knee System (All-poly Tibial Plate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxx Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 13, 2025 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 4 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Mar 13, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K936079 (1994). 28 ancestors in all, the oldest K810520 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 4 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 3 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 2 generations backK090411 Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc. · 2009
- 1 generation backK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
- This deviceK250382 Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261563 Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −4 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −3 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −2 | K090411 | Freedom Metal Backed Tibial Component | Maxx Orthopedics, Inc. | 2009 | — |
| −1 | K131481 | Freedom PCK Components | Maxx Orthopedics, Inc. | 2014 | — |
| 0 (this device) | K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K082019 | Freedom Total Knee SystemSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code K082019 Freedom All-poly Tibial Baseplate JWH K090 411… | 2009 |
| * | K090411 | Freedom Metal Backed Tibial ComponentSummary page 5…Product Code K082019 Freedom All-poly Tibial Baseplate JWH K090 411 Freedom Metal Tibial baseplate JWH K18257 4… | 2009 |
| * | K182574 | Freedom Ultra-Congruent CR Tibial LinerSummary page 5…JWH K090 411 Freedom Metal Tibial baseplate JWH K18257 4 Freedom UC Tibial Liner JWH K2 43277… | 2019 |
| * | K243277 | Freedom® Medial Congruent LinerSummary page 5…JWH K18257 4 Freedom UC Tibial Liner JWH K2 43277 Freedom MC Tibial Liner JWH K131481… | 2024 |
| * | K131481 | Freedom PCK ComponentsSummary page 5…JWH K2 43277 Freedom MC Tibial Liner JWH K131481 FREEDOM PCK COMPONENTS JWH Device Descri… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | 2026 | 0 |
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 31 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 10 of the 28 ancestors have a recall of any class.
- Of its descendants, K261563 (Maxx Orthopedics, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K082019.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
* Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
* Correction of functional deformities.
* Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
* Moderate valgus, varus, or flexion trauma.
* Knee fractures untreatable by other methods.
* Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250382: Freedom Total Knee System (All-poly Tibial Plate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250382
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