# K051223: Hipstar Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: May 10, 2006 after 363 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871453 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.

## Most influential descendants
- K063822: Modification to Hipstar Femoral Stem (2007), 0 descendants of its own

## Recalls of this device
- Aug 20, 2008 · Not classified · Z-0227-2009: The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.

## Indications for use
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * rheumatoid arthritis (excepting the Osteolock TM 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. When mated with a constrained acetabular liner the H-ipstar® Hip Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. The Hipstar® Hip Stem is intended for cementless use only.

Source page: https://510kreport.com/device/K051223
Methodology: https://510kreport.com/methodology