# K130652: Vitalite E Cross-Linked Polyethylene Acetabular Insert

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Dec 17, 2013 after 280 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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: 8 generations back to K931641 (1994). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100933: Consensus CS2 Plus Acetabular Insert, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert, Hayes Medical, Inc. (2007) Summary page 2.
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene, Hayes Medical, Inc. (2002) Summary page 2.
- K122773: Cross-Over Acetabular Shell & Liner, Stelkast Company (2012) Summary page 2.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 2.
- K112802: Pipeline Total Hip System, Pipeline Orthopedics (2012) Summary page 2.

## Indications for use
The Consensus CS2TM Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, C52 Hip System, or UJNISYNTM Hip System for the following indications: 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, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

Source page: https://510kreport.com/device/K130652
Methodology: https://510kreport.com/methodology