510(k) · Cleared
ClearedFreedom (R) - TiNbN Coated Knee
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 Nov 18, 2020 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 4 other predicates after a 226-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 18, 2020
- Review
- 226 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K936079 (1994). 36 ancestors in all, the oldest K810520 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 5 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 4 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 3 generations backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- 2 generations backK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- 1 generation backK182872 LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
- This deviceK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK212839 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK222816 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −6 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −5 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −4 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −3 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| −2 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| −1 | K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019 | — |
| 0 (this device) | K200912 | Freedom (R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | 2020 | — |
| +1 | K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2021 | — |
| +2 | K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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…Manufacturer Trade name 510(k) device device category K082019(Femoral PS Component),… | 2009 |
| * | K090411 | Freedom Metal Backed Tibial ComponentSummary page 5…PS Component), Maxx Freedom® Total K090411(Tibial Predicate device Orthopedics Knee System Base… | 2009 |
| * | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentSummary page 5…Knee System Base Plate), Inc., USA K091280( Femoral CR Component)… | 2009 |
| * | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Summary page 5…Foundation® PS (Encore Knee Knee System with K122239 Medical, L.P.), Reference TiNbN coating, 3D… | 2013 |
| * | K182872 | LINK GEMINI SL Total Knee SystemSummary page 5…coating Waldemar Link LINK® Gemini® GmbH & Co. SL® Total Knee K182872 KG, Germany System 5.7 Device Description: The Freedom® - TiNbN Coated Knee comprise… | 2019 |
| † | K172936 | Destiknee™ Total Knee System | 2017 |
| † | K160771 | Destiknee Total Knee System | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212839 | Opulent TiNbN Coated Knee | 2021 | 1 |
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 26 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 15 of the 36 ancestors have a recall of any class.
- Of its descendants, K212839 (Meril Healthcare Pvt., Ltd., 2021) has gone furthest, with 1 descendant 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. 2020, 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?
The Freedom® - TiNbN Coated Knee is indicated for the following:
• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/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.
The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200912: Freedom (R) - TiNbN Coated Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200912
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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