510(k) · Cleared
ClearedFreedom Cementless Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxx Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jun 26, 2015 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 2 other predicates after a 101-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Jun 26, 2015
- Review
- 101 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
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 deviceK150680 Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025 · 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) | K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics, Inc. | 2015 | — |
| +1 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
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 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 4…Class Code Number number Primary K082019 21 CFR § Freedom Total Knee system… | 2009 |
| * | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentSummary page 4…21 CFR § Freedom Total Knee system II JWH K091280 888.3560… | 2009 |
| * | K131481 | Freedom PCK ComponentsSummary page 4…888.3560 K131481 Optetrak Logic® Porous Femoral Reference 21 CFR §… | 2014 |
| † | K140302 | Optetrak Logic Porous Femoral Components | 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 |
|---|---|---|---|
| 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 21 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 11 of the 28 ancestors have a recall of any class.
- Of its descendants, K253314 (Maxx Orthopedics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K082019.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and 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.…
Read the full statement (122 words)
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and 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
Revision surgery where sufficient bone stock and soft tissue integrity are present.
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150680: Freedom Cementless Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150680
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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