# K252846: TaperSet™ Hip System

- Pathway: 510(k) (Special)
- Applicant: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
- Decided: Nov 20, 2025 after 73 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). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141043: CS2 Multi-Hole Acetabular Shell, Consensus Orthopedics, Inc. (2014) Summary page 5.
- K102399: Consensus Taperset Hip System, Consensus Orthopedics, Inc. (2010) Summary page 4.

## Indications for use
The indications for use for TaperSet™ Hip System are: The TaperSet™ Hip System is designed for total hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System including the CS2™ Acetabular Cup 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. The Consensus acetabular cup components are intended for cemented or cementless use. The CS2 Ti plasma coated acetabular shell is intended for cementless use. The Consensus all-poly acetabular cup is intended for cemented use. The intended use or indications for use of the TaperSet™ Hip System are similar to its original clearance K102399 except the removal of ‘partial hip arthroplasty” as the DAA surgical technique is only applicable to the total hip system.

Source page: https://510kreport.com/device/K252846
Methodology: https://510kreport.com/methodology