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Z-Series Modular Total Hip System

by Osteoimplant Technology, Inc.

510(k) K032729

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032729 Date3 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Z-Series Modular Total Hip System is a modular orthopedic implant designed for total or partial hip arthroplasty. It consists of femoral and acetabular components with a CP Titanium plasma coating, intended for cemented or press-fit fixation to restore hip joint function and alleviate severe pain caused by degenerative or traumatic joint damage.

This system is used in clinical and hospital settings by orthopedic surgeons for hip replacement procedures. Components are supplied sterile for single-use, with modularity allowing customisation to address specific anatomical requirements. The device holds an FDA 510(k) clearance under product code LPH, classified under the Orthopedic Advisory Committee for traditional review.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Z-Series Modular Total Hip System used for?

    The Z-Series Modular Total Hip System is designed for total or partial hip arthroplasty to restore joint function and relieve severe pain caused by degenerative or traumatic joint damage. Its modular components allow customisation to fit specific anatomical needs, making it suitable for both cemented and press-fit fixation methods.

  • How is the Z-Series Modular Total Hip System supplied?

    The system is supplied sterile and intended for single-use only. This ensures optimal infection control and compliance with clinical standards for orthopedic implants.

  • What materials are used in the Z-Series Modular Total Hip System?

    The femoral and acetabular components of the Z-Series Modular Total Hip System feature a CP Titanium plasma coating, which enhances biocompatibility and fixation stability during hip replacement procedures.

  • Is the Z-Series Modular Total Hip System reusable?

    No, the Z-Series Modular Total Hip System is designed for single-use only. Single-use implants reduce the risk of cross-contamination and ensure patient safety by maintaining sterility throughout the procedure.

  • What regulatory clearance does the Z-Series Modular Total Hip System hold?

    The Z-Series Modular Total Hip System holds FDA 510(k) clearance under product code LPH, classified under the Orthopedic Advisory Committee for traditional review. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards.