# K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert

- Pathway: 510(k) (Special)
- Applicant: Hayes Medical, Inc.
- Decided: Jan 31, 2007 after 26 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810258 (1981). 10 ancestors in all.
38 later devices descend from it; 7 cite it directly.
0 of 49 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.
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene, Hayes Medical, Inc. (2002) Summary page 1.
- K994415: Marathon Cross-Linked Polyethylene Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K100933: Consensus CS2 Plus Acetabular Insert (2010), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K121935: Taperset Hip Small Stems (2012), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own

## Indications for use
Indications for use with the CONSENSUS® Hip System or UNISYN TM Hip Ssytem 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 Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

Source page: https://510kreport.com/device/K070061
Methodology: https://510kreport.com/methodology