# K043079: Bicontact Hip System with U-Cap

- Pathway: 510(k) (Special)
- Applicant: Aesculap
- Decided: Dec 8, 2004 after 30 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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
Longest line of descent: 5 generations back to K955033 (1996). 32 ancestors in all.
166 later devices descend from it; 3 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040191: Bicontact Hip Stem and Femoral Head, Aesculap (2004) Summary page 2.
- K023102: Accolade TMZF Plus HA 127 Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 2.
- K020963: Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K953111: Corail, Landos, Inc. (1996) Summary page 2.

## Most influential descendants
- K093472: Trinity Acetabular System (2010), 117 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own

## Indications for use
The BiContact Hip System with p-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint. The device is intended for: * Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. * Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral eptiphysis * Patients suffering from disability due to previous fusion * Patients with acute femoral neck fractures

Source page: https://510kreport.com/device/K043079
Methodology: https://510kreport.com/methodology