# K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 11, 2003 after 217 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854046 (1985). 15 ancestors in all.
208 later devices descend from it; 6 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984296: Lateralized Intergral Porous Primary Femoral Component, Biomet, Inc. (1999) Summary page 1.
- K984408: 130 Modified Integral Femoral Component, Biomet, Inc. (1999) Summary page 1.
- K960303: Fenning Femoral Component, Biomet, Inc. (1996) Summary page 1.
- K982367: Reach Hip Component, Biomet, Inc. (1998) Summary page 1.
- K000760: Reach Femoral Component, Biomet, Inc. (2000)

## Most influential descendants
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K050124: Porous Coated Acetabular Components (2005), 138 descendants of its own
- K070369: Regenerx Ringloc + Modular Acetabular Shells (2007), 137 descendants of its own
- K093235: Ringloc + Hybrid Acetabular System (2010), 65 descendants of its own
- K121874: G7 Acetabular System (2012), 53 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0523-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- Apr 16, 2015 · Class III · Z-1754-2015: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
- Jan 9, 2015 · Class II · Z-1122-2015: Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

## Indications for use
1) Noninflammatory 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 throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5) Revision of previously failed total hip arthoplasty.

Source page: https://510kreport.com/device/K030055
Methodology: https://510kreport.com/methodology