# K121935: Taperset Hip Small Stems

- Pathway: 510(k) (Special)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Sep 10, 2012 after 70 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). 80 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 101 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.
- K103755: Taperloc Complete, Size 5 and 6, Biomet Manufacturing Corp (2011) Summary page 2.

## 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 TaperSetTM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus 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, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The TaperSet TM hip stem is indicated for cementless use.

Source page: https://510kreport.com/device/K121935
Methodology: https://510kreport.com/methodology