# K060635: Consensus Acetabular Shell System

- Pathway: 510(k) (Special)
- Applicant: Hayes Medical, Inc.
- Decided: Apr 28, 2006 after 49 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: 5 generations back to K930712 (1993). 14 ancestors in all.
69 later devices descend from it; 6 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 1.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 1.
- K031110: Apex Modular Acetabular Cup, Apex Surgical, LLC (2003) Summary page 1.
- K022711: Modification to Avalon Cup System, Orthopedic Source, Inc. (2002) Summary page 1.
- K974095: Foundation Porous Coated Flared Rim Shell, Encore Orthopedics, Inc. (1998) Summary page 1.

## Most influential descendants
- K112802: Pipeline Total Hip System (2012), 53 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K141043: CS2 Multi-Hole Acetabular Shell (2014), 21 descendants of its own
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own

## Indications for use
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 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.

Source page: https://510kreport.com/device/K060635
Methodology: https://510kreport.com/methodology