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COPAL® exchange G hip spacer - COPAL® exchange G hip spacer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K234028

by Heraeus Medical GmbH

Identifiers

510(k) Number
K234028 FDA 510(k)
FDA Product Code
KWL FDA 510(k)
Models / Variants
COPAL® exchange G hip spacer FDA 510(k)
COPAL® G+V FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3360 FDA 510(k)
Regulation Number
888.3360 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The COPAL exchange G hip spacer is a temporary hip replacement device made of polymethylmethacrylate (PMMA) with gentamicin, intended for use in skeletally mature patients undergoing a two-stage procedure due to a septic process. It is designed for temporary use with a maximum duration of 180 days. The device includes internal AISI 316L stainless steel reinforcement and is used in conjunction with the COPAL G+V bone cement.

The COPAL G+V is a high-viscosity, radiopaque PMMA bone cement containing gentamicin and vancomycin, used for fixation of the COPAL exchange G hip spacer to the host bone. It provides high local concentrations of antibiotics with a low systemic load. The device is supplied in various sizes and is regulated under FDA 510(k) clearance with product code KWL.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: COPAL exchange G - Heraeus Medical, COPAL G+V - Heraeus Medical, COPAL® exchange G hip spacer; COPAL® G+V (K234028) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Heraeus Medical GmbH

Sources (1)

  • FDA 510(k) K234028 24 fields · synced Oct 6, 2026