# K853730: Freeman-Samuelson Mark II Press-Fit Total Knee Rep

- Pathway: 510(k) (Traditional)
- Applicant: Protek, Inc.
- Decided: Feb 18, 1986 after 165 days
- Product code: MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, 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
No predicates in its family tree.
81 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030623: Smith & Nephew Profix Total Knee System (2003), 78 descendants of its own
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), 60 descendants of its own
- K060303: Vanguard PS Open Box Porous Femoral Components (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K051229: Profix  Flex Cruciate Retaining Articular Insert (2005), 14 descendants of its own

Source page: https://510kreport.com/device/K853730
Methodology: https://510kreport.com/methodology