# K040191: Bicontact Hip Stem and Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap
- Decided: Aug 25, 2004 after 210 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
Longest line of descent: 4 generations back to K955033 (1996). 28 ancestors in all.
267 later devices descend from it; 8 cite it directly.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 2.
- K023102: Accolade TMZF Plus HA 127 Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 2.
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series, Zimmer, Inc. (2003) Summary page 2.
- K022902: Smith & Nephew Hip System, Smith & Nephew, Inc. (2002) Summary page 2.
- K041109: Zimmer Anatomic II Hip Prosthesis, Zimmer, Inc. (2004). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K043079: Bicontact Hip System with U-Cap (2004), 166 descendants of its own
- K093472: Trinity Acetabular System (2010), 117 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 descendants of its own

## Indications for use
The BiCONTACT Hip System (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 epiphysis * Patients suffering from disability due to previous fusion Patients with acute femoral neck fractures

Source page: https://510kreport.com/device/K040191
Methodology: https://510kreport.com/methodology