# K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Sep 25, 2009 after 147 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934589 (1994). 13 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082019: Freedom Total Knee System, Maxx Orthopedics, Inc. (2009) Summary page 1.
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998). 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”.

## Most influential descendants
- K160771: Destiknee Total Knee System (2016), 3 descendants of its own
- K200912: Freedom (R) - TiNbN Coated Knee (2020), 2 descendants of its own
- K172936: Destiknee™ Total Knee System (2017), 2 descendants of its own
- K212839: Opulent TiNbN Coated Knee (2021), 1 descendant of its own
- K150680: Freedom Cementless Femoral Component (2015), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091280
Methodology: https://510kreport.com/methodology