# K021403: HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: May 31, 2002 after 29 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921181 (1994). 3 ancestors in all.
132 later devices descend from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921181: Mallory-Head Total Hip System, Biomet, Inc. (1994) Summary page 1.
- K000538: Mallory/Head Lateralized Press-Fit Femoral, Biomet, Inc. (2000) Summary page 1.
- K003429: Malloy/Head Lateralized Press-Fit Femoral, Biomet, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K083495: Modification to: Metha Hip System (2009), 59 descendants of its own

## Indications for use
The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K021403
Methodology: https://510kreport.com/methodology