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Biopro Metal Backed Cemented Acetabular Cup

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910352

by Biopro, Inc.

Identifiers

510(k) Number
K910352 FDA 510(k)
FDA Product Code
JDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3350 FDA 510(k)
Regulation Number
888.3350 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a metal-backed cemented acetabular cup, a type of orthopedic implant used in hip arthroplasty. It is designed to replace the acetabular component of the hip joint and is fixed in place using bone cement.

The device is supplied as a single-use implant and is intended for use in surgical settings. It received FDA 510(k) clearance (K910352) on June 13, 1991, and is classified under product code JDI. No information regarding sterility, MRI safety, sizes, or storage conditions is provided in the data.

Frequently asked questions

What is the BIOPRO Metal Backed Cemented Acetabular Cup used for?

It is used to replace the acetabular component of the hip joint in hip arthroplasty procedures, providing a stable articulating surface when fixed with bone cement.

How is the BIOPRO Metal Backed Cemented Acetabular Cup supplied and is it reusable?

The device is supplied as a single-use implant and is intended for one-time use only in surgical settings; it is not designed for cleaning, resterilization, or reuse.

What regulatory pathway was used for the BIOPRO Metal Backed Cemented Acetabular Cup and when was it cleared?

It received FDA 510(k) clearance through a traditional submission process, with clearance granted on June 13, 1991, under K910352, based on substantial equivalence to a predicate device.

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: BIOPRO METAL BACKED CEMENTED ACETABULAR CUP (K910352) — FDA 510(k ..., PDF K910352 - Biopro Metal Backed Cemented Acetabular Cup, Biopro Metal Backed Cemented Acetabular Cup 510 (k) FDA Premarket ..., LINK - Cemented Acetabular Cup System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biopro, Inc.

Sources (1)

  • FDA 510(k) K910352 24 fields · synced Sep 21, 2026