# K923911: Intrinsic Stem

- Pathway: 510(k) (Traditional)
- Applicant: Turnkey Intergration USA, Inc.
- Decided: Apr 14, 1993 after 253 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K021109: Esop CO-CR Femoral Heads (2002), 1 descendant of its own
- K964878: Esop S/C Femoral Stem (1998), 1 descendant of its own
- K050556: Alumina Head (2005), 0 descendants of its own
- K021108: Esop HA Femoral Stem (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K923911
Methodology: https://510kreport.com/methodology