# K990830: Mallory/Head Calcar Replacement with Interlocking Slots BI-Metric Porous Collared Stem with Interlocking Slots

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 11, 2000 after 396 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.
39 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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
- K151739: Revision Femoral Stem (2015), 7 descendants of its own

## Indications for use
Interlocking hip stems 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/K990830
Methodology: https://510kreport.com/methodology
