# K102399: Consensus Taperset Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Dec 2, 2010 after 100 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). 77 ancestors in all.
33 later devices descend from it; 7 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 2.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) 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 2.
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 2.
- K922560: Consensus (TM) Bipolar System, U.S. Medical Products, Inc. (1992) Summary page 2.
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert, Hayes Medical, Inc. (2007) Summary page 2.
- K953792: Consensus Zirconia Head Size -3.5, 0, +5, U.S. Medical Products, Inc. (1995) Summary page 2.
- K955386: Consensus Zirconia Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960339: Consensus 22MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960156: Consensus 32MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960151: Consensus 26MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996). Our reading of the summary gave K960155, FDA’s number for Unitron Model Sound F/XP (Unitron Industries, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CONSENSUS 26MM COCRMO FEMORAL HEAD”.
- K060635: Consensus Acetabular Shell System, Hayes Medical, Inc. (2006) Summary page 2.
- K030205: Consensus Unipolar Head, Cocr, Hayes Medical, Inc. (2003) Summary page 2.
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene, Hayes Medical, Inc. (2002)
- K020153: Consensus Acetablar Shell, TI Coated, Hayes Medical, Inc. (2002) Summary page 2.
- K953198: Corticellous Bone Screw, Hayes Medical, Inc. (1995) Summary page 2.
- K100933: Consensus CS2 Plus Acetabular Insert, Consensus Orthopedics, Inc. (2010). Cleared while this submission was under review Summary page 2.

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

## Indications for use
The TaperSet™ 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. The TaperSet™ hip stem is indicated for cementless use.

Source page: https://510kreport.com/device/K102399
Methodology: https://510kreport.com/methodology