# K061168: Pca 36MM Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 18, 2006 after 82 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) PCA® Femoral Heads: named in the summary without a submission number

## Indications for use
Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis (except the OsteolockTM HA Acetabular Cup); Correction of functional deformity; Revision procedures where other treatments or devices have failed; and, Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K061168
Methodology: https://510kreport.com/methodology