# K936127: Howmedica Premium Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Oct 26, 1994 after 307 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 3 cite it directly.
0 of 49 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
- K974054: Distal Centralizer, Exeter II Hip System (1997), 45 descendants of its own
- K980843: Exeter Intramedullary Bone Plug (1998), 44 descendants of its own
- K982918: Depuy C-Stem System (1998), 25 descendants of its own
- K042959: Depuy C-Stem Amt Hip Prosthesis (2004), 23 descendants of its own
- K082239: Depuy C-Stem Amt (2008), 14 descendants of its own

## Recalls of this device
- Dec 29, 2011 · Class II · Z-1982-2012: Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

Source page: https://510kreport.com/device/K936127
Methodology: https://510kreport.com/methodology