# K920034: Duracon Modular Femoral Component and Femoral Spac

- Pathway: 510(k) (Traditional)
- Applicant: Pfizer Hospital Products Group, Inc.
- Decided: Mar 18, 1992 after 72 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963796: Kinemax Plus Modular Stabilizer Femoral Component and Femoral Spacers (1996), 0 descendants of its own

## Recalls of this device
- Oct 17, 2006 · Not classified · Z-1241-2007: Loose fixation pegs: One lot of femoral components may have loose fixation pegs.
- Oct 5, 2006 · Not classified · Z-0014-2011: Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.

Source page: https://510kreport.com/device/K920034
Methodology: https://510kreport.com/methodology