# K973302: Foundation Porous Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Dec 2, 1997 after 90 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.
248 later devices descend from it; 2 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K982367: Reach Hip Component (1998), 209 descendants of its own
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components (2003), 208 descendants of its own
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K050124: Porous Coated Acetabular Components (2005), 138 descendants of its own
- K070369: Regenerx Ringloc + Modular Acetabular Shells (2007), 137 descendants of its own

## Indications for use
The indications for use of the Foundation® Porous total hip replacement prosthesis include: degenerative joint diseasc including osteoarthritis and avascular necrosis; rheumatoid arthritis; 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, which is unmanageable using other techniques. This stem is intended to be used in a cementless mode.

Source page: https://510kreport.com/device/K973302
Methodology: https://510kreport.com/methodology