# K141043: CS2 Multi-Hole Acetabular Shell

- Pathway: 510(k) (Special)
- Applicant: Consensus Orthopedics, Inc.
- Decided: May 19, 2014 after 26 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: 6 generations back to K930712 (1993). 15 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 37 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 3.
- K060635: Consensus Acetabular Shell System, Hayes Medical, Inc. (2006) Summary page 3.

## Most influential descendants
- 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
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own

## Indications for use
The C52Th Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, C52Th HIP SYSTEM, and the TAPERSET h HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS®D HIP SYSTEM. The 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 fermoral 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 tumiorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2Th and TAPERSETmu hip stems are indicated for cementless use. The UNISYN"' HIP SYSTEM is indicated for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. A. Proximal fermoral fractures. B. Avascular necrosis of the femoral head. C. Non-union of proximal femoral neck fractures. D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vats, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYN' stems used with roughened and plasma coated bodies are intended for cemented or unceniented use. UNISYN" stems used with plasma/HA or HA coated bodies ame intended for uncemented use only.

Source page: https://510kreport.com/device/K141043
Methodology: https://510kreport.com/methodology