# K953977: Primaloc Cementless Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jan 26, 1996 after 156 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K132697: Encompass 10/12 Hip Stem (2014), 0 descendants of its own
- K050556: Alumina Head (2005), 0 descendants of its own
- K021108: Esop HA Femoral Stem (2002), 0 descendants of its own

## Recalls of this device
- Dec 26, 2002 · Not classified · Z-0567-03: Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Dec 26, 2002 · Not classified · Z-0566-03: Cleaning agent residue from packaging material was adhering to implantable hip stems.

Source page: https://510kreport.com/device/K953977
Methodology: https://510kreport.com/methodology