# K120595: Unisyn Plus Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Oct 12, 2012 after 227 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K921308 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003649: Triton Hip System, Hayes Medical, Inc. (2001) Summary page 2.
- K062383: Unisyn HA Plasma Modular Hip, Hayes Medical, Inc. (2006) Summary page 2.

## Indications for use
Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. A. Proximal femnoral fractures. B. Avascular necrosis of the femoral head. C. Non-union of proximal femoral neck fractures. D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tunmorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYNTM assemblies with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYNTh assemblies with plasmalliA or HA coated bodies are intended for uncemented use only.

Source page: https://510kreport.com/device/K120595
Methodology: https://510kreport.com/methodology