# K003429: Malloy/Head Lateralized Press-Fit Femoral

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Nov 30, 2000 after 27 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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.
144 later devices descend from it; 2 cite it directly.
0 of 145 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
- K021403: HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral Stem (2002), 132 descendants of its own
- K043123: Apex Modular HA Hip Stem (2005), 131 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own
- K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] (2008), 61 descendants of its own
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own

## Recalls of this device
- Apr 16, 2015 · Class III · Z-1754-2015: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Source page: https://510kreport.com/device/K003429
Methodology: https://510kreport.com/methodology