# K934060: Howmedica (R) Acetabular Comp Pack/Manuf Meth Change

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Aug 18, 1995 after 729 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
37 later devices descend from it; 4 cite it directly.
0 of 38 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
- K993352: Crossfire System 12 Acetabular Inserts (1999), 18 descendants of its own
- K972792: Duration Stabilized Uhmwpe Acetabular Components (1997), 16 descendants of its own
- K992153: PE-Plus Acetabular Cup (1999), 15 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K111546: U2 Hip System (2011), 13 descendants of its own

Source page: https://510kreport.com/device/K934060
Methodology: https://510kreport.com/methodology