# K042774: Mallory-Head Modular Calcar Stems with Interlocking Slots

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 21, 2005 after 108 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: 4 generations back to K921274 (1994). 8 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990830: Mallory/Head Calcar Replacement with Interlocking Slots BI-Metric Porous Collared Stem with Interlocking Slots, Biomet, Inc. (2000) Summary page 1.
- K031693: Mallory/Head  Modular Calcar with and Without HA, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K151739: Revision Femoral Stem (2015), 7 descendants of its own
- K100469: Arcos Interlocking Distal Stems (2010), 7 descendants of its own

## Indications for use
Mallory-Head® Modular Calcar Stems with Interlocking Slots are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.

Source page: https://510kreport.com/device/K042774
Methodology: https://510kreport.com/methodology