Product Code: MBB FDA class 2 21 CFR 888.3027

Bone Cement, Antibiotic

Orthopedic

Antibiotic bone cement is an orthopedic implant material used to fix prosthetic components to bone during joint replacement surgery while simultaneously releasing antibiotics locally to reduce the risk of periprosthetic infection. It is classified as FDA Class II under 21 CFR 888.3027 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBB and it carries an implant flag. Full GMP compliance is required and the device does not sustain life.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MBB
Device Class: FDA class 2
Regulation Number: 888.3027
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252443	SpaceFix Shoulder Spacer	Sep 15, 2025	Substantially Equivalent	G21, S.R.L.
K242216	GENTAFIX® (1, 3, 3MV)	Dec 18, 2024	Substantially Equivalent	Teknimed Sas
K240856	Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds	Nov 20, 2024	Substantially Equivalent	Osartis GmbH
K222760	StageOne Select Hip Cement Spacer Molds	Dec 28, 2022	Substantially Equivalent	Biomet, Inc.
K221968	StageOne Shoulder Cement Spacer Molds	Sep 15, 2022	Substantially Equivalent	Biomet, Inc.
K213287	StageOne Knee Cement Spacer Molds	Sep 02, 2022	Substantially Equivalent	Biomet, Inc.
K202338	SpaceFlex Shoulder	Feb 17, 2021	Substantially Equivalent	G21, S.R.L.
K201960	SpaceFlex Knee - 80mm Size	Aug 13, 2020	Substantially Equivalent	G21, S.R.L.
K192041	G21 SpaceFlex Hip	Oct 29, 2019	Substantially Equivalent	G21, S.R.L.
K190216	SpaceFlex Knee	Jun 09, 2019	Substantially Equivalent	G21, S.R.L.
K161273	StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis	Jan 25, 2017	Substantially Equivalent	Biomet, Inc.
K161166	StageOne Select Cement Spacer Molds for Temporary Hip Replacement	Sep 08, 2016	Substantially Equivalent	Biomet, Inc.
K160071	StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis	Jun 16, 2016	Substantially Equivalent	Biomet, Inc.
K150850	Refobacin Bone Cement R	Jul 16, 2015	Substantially Equivalent	Biomet, Inc.
K131135	BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS	Jan 22, 2014	Substantially Equivalent	Biomet Manufacturing Corp
K081163	SMARTSET GMV GENTAMICIN BONE CEMENT	May 14, 2008	Substantially Equivalent	DePuy Orthopaedics, Inc.
K063857	SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT	Feb 26, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K061144	DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT	Jun 08, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K053002	DEPUY CMW 1 GENTAMICIN BONE CEMENT	Nov 22, 2005	Substantially Equivalent	DePuy Orthopaedics, Inc.