# K072154: Foundation (FMP) Porous Coated Spiked Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Dec 14, 2007 after 133 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 1 generation back to K973302 (1997). 4 ancestors in all.
61 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974093: Foundation Porous Coated Hemispherical Shell, Encore Orthopedics, Inc. (1998) Summary page 1.
- K974095: Foundation Porous Coated Flared Rim Shell, Encore Orthopedics, Inc. (1998) Summary page 1.
- K973119: Foundation Porous Acetabular System, Encore Orthopedics, Inc. (1998) Summary page 1.
- K973302: Foundation Porous Hip Stem, Encore Orthopedics, Inc. (1997) Summary page 1.

## Most influential descendants
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner (2013), 38 descendants of its own
- K141006: RSP Humeral Socket Insert (2014), 21 descendants of its own
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (2017), 18 descendants of its own
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own

## Recalls of this device
- Feb 7, 2014 · Class II · Z-1130-2014: Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the p

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; · rheumatoid arthritis; * correction of functional deformity; * femoral fracture. This device may also be indicated in the salvage of previously failed surgical attempts. It is to be used for cementless applications only.

Source page: https://510kreport.com/device/K072154
Methodology: https://510kreport.com/methodology