# K051407: Legend All-Poly Cup

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Sep 8, 2005 after 100 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended for cemented use only in hip arthroplasty applications whose indications include: 1. Osteoarthritis, Rheumatoid arthritis, or other Osteoarthrosis 2. Certain femoral neck fractures or dislocation 3. Post traumatic arthritis 4. Idiopathic avascular necrosis of the femoral head 5. Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis 6. Previously failed surgery

Source page: https://510kreport.com/device/K051407
Methodology: https://510kreport.com/methodology