# K965156: Ultima*Unipolar Head and Adapter Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jan 24, 1997 after 32 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.
126 later devices descend from it; 5 cite it directly.
0 of 127 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) Johnson & Johnson ULTIMA* Unipolar Modular Head: named in the summary without a submission number
- (no number) Howmedica Unitrax Unipolar System: 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 ULTIMA®* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to: 1. femoral neck fracture, 2. avascular necrosis of the femoral head, 3. osteoarthritis, 4. abnormalities where: the major pathology affects the femoral head, the acetabular cavity is normal and not deformed or weakened, acetabular replacement is not required or desirable.

Source page: https://510kreport.com/device/K965156
Methodology: https://510kreport.com/methodology