510(k) · Cleared
ClearedFreedom Total Knee Cruciate Retaining (CR) Femoral Component
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 Sep 25, 2009 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 1 other predicate after a 147-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Sep 25, 2009
- Review
- 147 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934589 (1994). 13 ancestors in all, the oldest K910990 (1991). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK934589 Kirschner Performance Total Knee System Porous CoatedKirschner Medical Corp. · 1994
- 2 generations backK021559 Ascent All-Poly PS Tibial BearingsBiomet, Inc. · 2002
- 1 generation backK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
- This deviceK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK160771 Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016
- Descendant · cites it directly · 2 of its ownK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK172936 Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK212839 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK150680 Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K160771Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016 · cites it directly3descendants
- K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020 · cites it directly2descendants
- K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd. · 2017 · 2 generations on2descendants
- K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021 · 2 generations on1descendant
- K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934589 | Kirschner Performance Total Knee System Porous Coated | Kirschner Medical Corp. | 1994 | — |
| −2 | K021559 | Ascent All-Poly PS Tibial Bearings | Biomet, Inc. | 2002 | — |
| −1 | K082019 | Freedom Total Knee System | Maxx Orthopedics, Inc. | 2009 | — |
| 0 (this device) | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral Component | Maxx Orthopedics, Inc. | 2009 | — |
| +1 | K160771 | Destiknee Total Knee System | Meril Healthcare Private Limited | 2016 | — |
| +1 | K200912 | Freedom (R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | 2020 | — |
| +2 | K172936 | Destiknee™ Total Knee System | Meril Healthcare Pvt., Ltd. | 2017 | — |
| +2 | K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2021 | — |
| +1 | K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K082019 | Freedom Total Knee SystemSummary page 1…al/Polymer Semi-Constrained Cemented Prosthesis -21 CFR §888.3560 3. PREDICATE DEVICES *Freedom Total Knee system subject of K0820 19 *Osteonics Scorpio Cruciate Retaining Total Knee System, subject of K974566 4. DEVICE DESCRIPTION The Maxx Orthoped… | 2009 |
| * | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee System Our reading of the summary gave K974566, FDA’s number for Mda Simplastin HTF (Organon Teknika Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Osteonics Scorpio Cruciate Retaining Total Knee System”. | 1998 |
| † | K090411 | Freedom Metal Backed Tibial Component | 2009 |
What descends from it? (7)
3 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 15 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K160771 (Meril Healthcare Private Limited, 2016) has gone furthest, with 3 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. 2009, 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® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following: * Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. *…
Read the full statement (122 words)
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:
* 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, and/or prior patellectomy.
* Moderate valgus, varus, or flexion trauma.
. Knee fractures untreatable by other methods
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component 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/K091280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091280
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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