# K063822: Modification to Hipstar Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Stryker Orthopaedics
- Decided: Jan 25, 2007 after 30 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871453 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051223: Hipstar Femoral Stem, Stryker Orthopaedics (2006) Summary page 2.

## Recalls of this device
- Sep 28, 2007 · Not classified · Z-0463-2008: Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

## Indications for use
noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite coated prostheses); correction of functional deformity; revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K063822
Methodology: https://510kreport.com/methodology