# K974807: Osteo Austin Moore Endoprosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Mar 16, 1998 after 83 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
No predicates in its family tree.
151 later devices descend from it; 2 cite it directly.
0 of 152 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 its predicate without a number.
- (no number) Howmedica Austin Moore Endoprosthesis, Howmedica Inc.: named in the summary without a submission number

## Most influential descendants
- K984028: The New Bio-Moore Endo Heads (1999), 117 descendants of its own
- 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

## Indications for use
The subject devices are intended for hemi-hip replacement. They are intended for cemented use only. Indications Femoral head/neck fractures Aseptic necrosis of the femoral head Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular involvement.

Source page: https://510kreport.com/device/K974807
Methodology: https://510kreport.com/methodology