# K121263: Taper Set Hip System RDP Stem

- Pathway: 510(k) (Special)
- Applicant: Consensus Orthopedics, Inc.
- Decided: May 22, 2012 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: 7 generations back to K930712 (1993). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 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.

## Cited in the summary but kept off the family tree
- K1001086: Biomet Taperloc Complete Hip System. Number could not be read

## 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 TaperSetTM hip stem is indicated for cementless use.

Source page: https://510kreport.com/device/K121263
Methodology: https://510kreport.com/methodology