# K062383: Unisyn HA Plasma Modular Hip

- Pathway: 510(k) (Special)
- Applicant: Hayes Medical, Inc.
- Decided: Dec 21, 2006 after 128 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: 5 generations back to K921308 (1994). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.
- K935453: Consensus (TM) Hip System-HA Coated Tianium Fem Stem, U.S. Medical Products, Inc. (1994) Summary page 1.
- K022549: Restoration Modular System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K022463: HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K120595: Unisyn Plus Hip Stem (2012), 0 descendants of its own

## Indications for use
Indications for use of the UNISYN TM HIP SYSTEM A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis. B) Revision of failed femoral head replacement, hip 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 plane, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

Source page: https://510kreport.com/device/K062383
Methodology: https://510kreport.com/methodology