# K001660: Mallory Head Modular Calcar

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jun 14, 2000 after 14 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.
48 later devices descend from it; 2 cite it directly.
0 of 49 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
- K031693: Mallory/Head  Modular Calcar with and Without HA (2003), 39 descendants of its own
- K042774: Mallory-Head Modular Calcar Stems with Interlocking Slots (2005), 38 descendants of its own
- K090757: Biomet Modular Femoral Revision System (2009), 37 descendants of its own
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; (2010), 27 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own

Source page: https://510kreport.com/device/K001660
Methodology: https://510kreport.com/methodology