# K100933: Consensus CS2 Plus Acetabular Insert

- Pathway: 510(k) (Special)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Oct 6, 2010 after 184 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 K930712 (1993). 32 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 68 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.
- K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene, Zimmer, Inc. (1999) Summary page 1.
- K994415: Marathon Cross-Linked Polyethylene Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K010171: Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner, DePuy Orthopaedics, Inc. (2001) Summary page 2.
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene, Hayes Medical, Inc. (2002) Summary page 2.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 2.
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert, Hayes Medical, Inc. (2007) Summary page 2.

## Most influential descendants
- 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
- K172501: iNSitu Total Hip System (2017), 7 descendants of its own

## Indications for use
In dications for use with the CONSENSUS® Hip System or UNISYN~m Hip System 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, cdxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and timorous 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/K100933
Methodology: https://510kreport.com/methodology