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Bio-Prep Cement Restrictor

by Biomedical Devices, Inc.

510(k) K931847

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

This device is named in the recall

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 NumberK931847 Date28 Jun 1994ClearedStatusActive

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-2600-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2599-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2598-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2596-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2597-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2602-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2601-2023 FDA Class II initiated 7 Aug 2023

    Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

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  • Withdrawn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
LZN
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

A cement obturator is a device used to restrict the flow of bone cement during orthopedic procedures. The Bio-Prep Cement Restrictor is a cement obturator designed for use in general and plastic surgery applications.

This device received FDA 510(k) clearance (K931847) on June 28, 1994, and is classified as a Class II medical device. It is supplied non-sterile and intended for single-use. The device is manufactured by Biomedical Devices, Inc. and is regulated under regulation number 878.3300 with product code LZN.

Other devices from Bio-Medical Devices, Inc.

See all devices from Bio-Medical Devices, Inc. →

Questions

AI-generated answers, 22 Sep 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 Bio-Prep Cement Restrictor used for?

    The Bio-Prep Cement Restrictor is a cement obturator designed to restrict the flow of bone cement during orthopedic procedures, specifically intended for use in general and plastic surgery applications as stated in its device description and regulatory classification.

  • Is the Bio-Prep Cement Restrictor sterile or non-sterile, and is it intended for single-use or reuse?

    The device is supplied non-sterile and is intended for single-use only, as explicitly specified in the device data under its description and specifications, meaning it should not be reprocessed or reused after initial application.

  • What regulatory pathway and clearance information applies to the Bio-Prep Cement Restrictor?

    The Bio-Prep Cement Restrictor received FDA 510(k) clearance under submission number K931847 on June 28, 1994, and is classified as a Class II medical device under regulation number 878.3300 with product code LZN, indicating it was found substantially equivalent to a predicate device.