# K000335: Mallory-Head Modular Calcar Total Hip System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 25, 2000 after 22 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
Longest line of descent: 1 generation back to K945115 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945115: Mallory-Head Modular Calcar Repacement Components, Biomet, Inc. (1995) Summary page 1.

## Indications for use
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional Geformity; 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; 5) revision of previously failed total hip arthroplasty due to recurrent dislocations.

Source page: https://510kreport.com/device/K000335
Methodology: https://510kreport.com/methodology