# K122512: CS2 Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Nov 5, 2012 after 80 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: 7 generations back to K930712 (1993). 78 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102399: Consensus Taperset Hip System, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K030151: Consensus Hip System, Unisyn Hip System, Hayes Medical, Inc. (2003) Summary page 2.
- K935193: Consensus Hip System- Porous Coated Titianium Femoral Stem, U.S. Medical Products, Inc. (1994) Summary page 2.
- K935453: Consensus (TM) Hip System-HA Coated Tianium Fem Stem, U.S. Medical Products, Inc. (1994) Summary page 2.
- K933499: Consensus Hip System- Non-Porous Titanium Femoral Stem, U.S. Medical Products, Inc. (1994) Summary page 3.
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 3.
- K922560: Consensus (TM) Bipolar System, U.S. Medical Products, Inc. (1992) Summary page 3.
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert, Hayes Medical, Inc. (2007) Summary page 3.
- K953792: Consensus Zirconia Head Size -3.5, 0, +5, U.S. Medical Products, Inc. (1995) Summary page 3.
- K955386: Consensus Zirconia Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 3.
- K960339: Consensus 22MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 3.
- K960156: Consensus 32MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 3.
- K960151: Consensus 26MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996)
- K060635: Consensus Acetabular Shell System, Hayes Medical, Inc. (2006) Summary page 3.
- K030205: Consensus Unipolar Head, Cocr, Hayes Medical, Inc. (2003) Summary page 3.
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene, Hayes Medical, Inc. (2002)
- K953198: Corticellous Bone Screw, Hayes Medical, Inc. (1995). Our reading of the summary gave K953199, FDA’s number for Metro 55G Toric & Spherical (Metrosoft, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Corticellous Bone Screw”.
- K100933: Consensus CS2 Plus Acetabular Insert, Consensus Orthopedics, Inc. (2010) Summary page 3.
- (no number) Consensus Acetabular Shell, Ti Coated: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K010542: SNN System Including the Tomoguide Option, Surgical Navigation Specialists, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K123782: Paragon Hip System (2013), 2 descendants of its own
- K142201: OMNI Interface Acetabular System (2015), 1 descendant of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Indications for use
The CS2TM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus 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 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. This CS2TM hip stem is indicated for cementless use. Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR: A. Primary replacement of the femoral head and neck with very little if any, acetabular degradation noted. B. Rheumatoid, osteo, and post-traumatic arthritis. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E. Non-unions of proximal femoral neck fractures. F. Revision of failed total hip arthroplasty. G. Treatment of malunion or nonunion acetabular fractures. The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

Source page: https://510kreport.com/device/K122512
Methodology: https://510kreport.com/methodology