510(k) · Cleared
ClearedFreedom Metal Backed Tibial 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 Apr 7, 2009 as substantially equivalent to K030686 (Exactech, Inc., 2003) after a 48-day review. Its family tree reaches back 3 generations to 1994. 15 later devices descend from it.
- Decided
- Apr 7, 2009
- Review
- 48 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936079 (1994). 11 ancestors in all, the oldest K810520 (1981). 15 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 2 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 1 generation backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- This deviceK090411 Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
- 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 · cites it directly · 1 of its ownK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · cites it directly6descendants
- 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
- K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −2 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −1 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| 0 (this device) | K090411 | Freedom Metal Backed Tibial Component | Maxx Orthopedics, Inc. | 2009 | — |
| +1 | K131481 | Freedom PCK Components | Maxx Orthopedics, Inc. | 2014 | — |
| +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 | — |
| +1 | K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial ComponentSummary page 1…l/polymer semi-constrained cemented prosthesis. 3. PREDICATE DEVICES * Exactech Optetrak Total Knee Tibial Components subject of K030686. 4. DEVICE DESCRIPTION The Maxx Orthopedics' Freedom® Metal Backed Tibial Component and Ultra High Molecular Weight Poly… | 2003 |
| † | K082019 | Freedom Total Knee System | 2009 |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131481 | Freedom PCK Components | 2014 | 6 |
| K160771 | Destiknee Total Knee System | 2016 | 3 |
| K200912 | Freedom (R) - TiNbN Coated Knee | 2020 | 2 |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | 2025 | 1 |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | 2025 | 1 |
| K161414 | Anatomic Total Knee System | 2017 | 1 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | 2026 | 0 |
| K253314 | Freedom Infinia™ Total Knee System | 2025 | 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 15 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K131481 (Maxx Orthopedics, Inc., 2014) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K030686.
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® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are designed to be used with the Freedom® Total Knee System. The Maxx Orthopedics' Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to: * Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. * Correction of…
Read the full statement (122 words)
The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are designed to be used with the Freedom® Total Knee System. The Maxx Orthopedics' Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:
* 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 Maxx Orthopedics' Freedom Total Knee System 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/K090411 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090411: Freedom Metal Backed Tibial Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090411
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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