# K984028: The New Bio-Moore Endo Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 19, 1999 after 68 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881288 (1988). 8 ancestors in all.
117 later devices descend from it; 1 cites it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954077: Unitrax V40 Modular Adaptor, Howmedica Corp. (1995) Summary page 2.
- K974807: Osteo Austin Moore Endoprosthesis System, Osteonics Corp. (1998) Summary page 2.
- K962646: Prime Modular Endo Head, Orthopaedic Innovations, Inc. (1996) Summary page 2.
- K960538: Opteon Unipolar, Exactech, Inc. (1996) Summary page 2.
- K965156: Ultima*Unipolar Head and Adapter Sleeves, Johnson & Johnson Professionals, Inc. (1997) Summary page 2.
- K845025: Austin-Moore Modular Hip Prosthesis, Biomet, Inc. (1985) Summary page 2.

## Most influential descendants
- K042037: M2A Magnum System (2004), 116 descendants of its own
- K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads (2006), 74 descendants of its own
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own

## Indications for use
a.) non-inflammatory degenerative joint disease, including avascular necrosis and osteoarthritis. b.) rheumatoid arthritis c.) correction of functional deformities d.) revision procedures where other devices or treatments have failed e.) treatment of non-unions, femoral neck trochanteric fractures of the proximal femur with neck involvement The New Bio-Moore Endo Heads are intended for impaction on either a press-fit or cemented femoral component and are for single use implants.

Source page: https://510kreport.com/device/K984028
Methodology: https://510kreport.com/methodology