# K962646: Prime Modular Endo Head

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Innovations, Inc.
- Decided: Sep 23, 1996 after 77 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.
118 later devices descend from it; 1 cites it directly.
0 of 119 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) Hemi-Head by Orthomet: named in the summary without a submission number
- (no number) Modular Cathcart Endoprosthesis System by DePuy: named in the summary without a submission number
- (no number) Unipolar Head by Smith and Nephew Richards: 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 Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.

Source page: https://510kreport.com/device/K962646
Methodology: https://510kreport.com/methodology