# K063816: Pca Alumina Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Feb 2, 2007 after 42 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003413 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023901: Alumina V40 Femoral Heads, Howmedica Osteonics Corp. (2003) Summary page 2.
- K920831: Pca Total Hip System (Cementless Use), Pfizer Hospital Products Group, Inc. (1992) Summary page 2.
- K003379: V-40/C-Taper Adapter Sleeve, Howmedica Osteonics Corp. (2000) Summary page 2.

## Indications for use
1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis (excepting the Osteolock HA Acetabular Cup and Peri-Apatite coated prostheses); 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA. Femoral head prostheses are indicated for use in cemented and cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.

Source page: https://510kreport.com/device/K063816
Methodology: https://510kreport.com/methodology