# K040685: Z - Series Modular Total Hip System Plasma Coated

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Jan 25, 2005 after 315 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
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 ZTM - Series Modular Total Hip System Plasma Coated 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, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral 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. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.

Source page: https://510kreport.com/device/K040685
Methodology: https://510kreport.com/methodology