# K032385: Global Press-Fit Stem

- Pathway: 510(k) (Traditional)
- Applicant: Global Medical Co.
- Decided: Oct 30, 2003 after 87 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
Longest line of descent: 1 generation back to K991226 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991226: Foundation Porous Hip Stem, Encore Orthopedics, Inc. (1999) Summary page 1.
- (no number) Progressive Hip: named in the summary without a submission number

## Indications for use
The Global Press-fit Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because of degenerative joint disease, including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.

Source page: https://510kreport.com/device/K032385
Methodology: https://510kreport.com/methodology