# K952191: Forged Cemented Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jul 17, 1995 after 69 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 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
- K961890: Foundation 9MM Forged Cemented Stem (1996), 5 descendants of its own
- K991227: 8MM Forged Cemented Stem (1999), 3 descendants of its own
- K031165: Plus Orthopedics Cemented Hip Stem (2003), 1 descendant of its own
- K243043: Origin™ Cemented Hip Stem (2025), 0 descendants of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K952191
Methodology: https://510kreport.com/methodology