# K974093: Foundation Porous Coated Hemispherical Shell

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jan 28, 1998 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.
145 later devices descend from it; 7 cite it directly.
0 of 146 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
- K072888: Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and Flared) (2008), 103 descendants of its own
- K112069: RSP Glenoid Baseplate Porous Coated (2011), 74 descendants of its own
- K072154: Foundation (FMP) Porous Coated Spiked Acetabular System (2007), 61 descendants of its own
- K140904: RSP Monoblock Stem with P2 Coating, Size 6 (2014), 55 descendants of its own
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner (2013), 38 descendants of its own

## Indications for use
The Foundation® Porous Coated Hemispherical Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture, and revision arthroplasty where bone loss is minimal. This system includes a metal-backed shell and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Source page: https://510kreport.com/device/K974093
Methodology: https://510kreport.com/methodology