# K021822: R120 Modular Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Jul 23, 2002 after 49 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 R120Thf Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoaitliritis, post-traumatic arthritis, collagen-disorders, avascular necrosis, traumatic and noli-union of feiiioral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Total Hip System is intended for use with and without bone ceiiieiit.

Source page: https://510kreport.com/device/K021822
Methodology: https://510kreport.com/methodology