# K242833: Legend® Acetabular Shell

- Pathway: 510(k) (Special)
- Applicant: Ortho Development Corp.
- Decided: Oct 11, 2024 after 22 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: 6 generations back to K930712 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161080: Escalade Legend Acetabular Shell, Ortho Development Corporation (2016) Summary page 5.

## Indications for use
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: • Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. • Previously failed hip surgery. • Fractures of the femoral neck or head. • Avascular necrosis of the femoral head. • Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Source page: https://510kreport.com/device/K242833
Methodology: https://510kreport.com/methodology