# K173951: Legend Acetabular Liners

- Pathway: 510(k) (Special)
- Applicant: Ortho Development Corporation
- Decided: May 30, 2018 after 154 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
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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K146631: Acetabular Cup System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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/K173951
Methodology: https://510kreport.com/methodology