# K960538: Opteon Unipolar

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 27, 1996 after 49 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: 1 generation back to K881288 (1988). 2 ancestors in all.
121 later devices descend from it; 2 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881288: Corin Modular Moore Stem, Orthopedic Systems, Inc. (1988) Summary page 1.
- K902365: Modular Unipolar System, Howmedica Corp. (1991) Summary page 1.

## 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 OPTEON Unipolar Endoprosthesis is for use with a modular femoral stem when hemiarthroplasty is indicated. The change to a total hip replacement can then be accomplished in the future without removing the femoral stem. The OPTEON Unipolar is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture.

Source page: https://510kreport.com/device/K960538
Methodology: https://510kreport.com/methodology