# K991226: Foundation Porous Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jun 1, 1999 after 50 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
No predicates in its family tree.
28 later devices descend from it; 3 cite it directly.
0 of 29 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
- K100445: Klassic HD Hip System (2010), 25 descendants of its own
- K143407: Klassic HD Hip System (2014), 16 descendants of its own
- K141972: Klassic HD Acetabular Insert with E-Link Poly (2014), 14 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K173104: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (2017), 6 descendants of its own

## Indications for use
The indications for use of the Foundation® Porous total hip replacement prosthesis include: 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 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/K991226
Methodology: https://510kreport.com/methodology