# K110542: Consensus Biolox Delta Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Apr 1, 2011 after 36 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: 9 generations back to K941847 (1994). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935193: Consensus Hip System- Porous Coated Titianium Femoral Stem, U.S. Medical Products, Inc. (1994) Summary page 2.
- K935453: Consensus (TM) Hip System-HA Coated Tianium Fem Stem, U.S. Medical Products, Inc. (1994)
- K933499: Consensus Hip System- Non-Porous Titanium Femoral Stem, U.S. Medical Products, Inc. (1994) Summary page 2.
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 2.
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert, Hayes Medical, Inc. (2007) Summary page 2.
- K953792: Consensus Zirconia Head Size -3.5, 0, +5, U.S. Medical Products, Inc. (1995) Summary page 2.
- K955386: Consensus Zirconia Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960339: Consensus 22MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960156: Consensus 32MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996)
- K960151: Consensus 26MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K060635: Consensus Acetabular Shell System, Hayes Medical, Inc. (2006) Summary page 2.
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene, Hayes Medical, Inc. (2002) Summary page 2.
- K020153: Consensus Acetablar Shell, TI Coated, Hayes Medical, Inc. (2002) Summary page 2.
- K953198: Corticellous Bone Screw, Hayes Medical, Inc. (1995) Summary page 2.
- K100933: Consensus CS2 Plus Acetabular Insert, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K030151: Consensus Hip System, Unisyn Hip System, Hayes Medical, Inc. (2003) Summary page 2.
- K102399: Consensus Taperset Hip System, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K081973: Metha Short Stem Hip System; Modular Hip System; Excia Hip System, Aesculap Implant Systems, Inc. (2008) Summary page 2.
- K082991: Biolox Delta Ceramic Femoral Head, Aesculap Implant Systems, Inc. (2008) Summary page 2.

## Indications for use
The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications. The general indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E. Non-union of proximal femoral neck fractures. F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

Source page: https://510kreport.com/device/K110542
Methodology: https://510kreport.com/methodology