Product Code: MBP FDA class 2 21 CFR 888.3045

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Orthopedic

The osteoinductive bone void filler (without human growth factor) is an orthopedic implant used to fill bone defects and promote new bone formation through osteoinduction, stimulating the body's own bone-forming cells without relying on exogenous human growth factors. It is classified as FDA Class II under 21 CFR 888.3045 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBP and it carries an implant flag. Full GMP quality system requirements apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MBP
Device Class: FDA class 2
Regulation Number: 888.3045
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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242799	PliaFX Flo	Nov 21, 2024	Substantially Equivalent	Lifenet Health
K143547	Vivorte Trabexus EB	Jan 14, 2015	Substantially Equivalent	Vivorte, Inc.
K130703	VIVORTE BVF	Sep 12, 2013	Substantially Equivalent	Vivorte, Inc.
K130498	OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY	May 31, 2013	Substantially Equivalent	Bacterin International, Inc.
K122513	CLEARED UNDER GRAFTON II EDBM	Mar 06, 2013	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K113728	SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY	Nov 15, 2012	Substantially Equivalent	Hans Biomed Corp.
K103742	ACCELL EVO3 (FORMERLY ACCELL A2I)	Mar 17, 2011	Substantially Equivalent	Integra Life Sciences
K091193	ACCELL EVO3C	Aug 10, 2009	Substantially Equivalent	Isotis Orthobiologics, Inc.
K080399	DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE	Oct 10, 2008	Substantially Equivalent	Musculoskeletal Transplant Foundation
K081817	ACCELL TBM-R	Sep 24, 2008	Substantially Equivalent	Isotis Orthobiologics, Inc.
K080405	SYGNAL DBM	Aug 28, 2008	Substantially Equivalent	Musculoskeletal Transplant Foundation
K080329	CAP PLUS, EQUIVABONE, CAP/DBM	Apr 28, 2008	Substantially Equivalent	Etex Corp.
K073329	SYGNAL DBM	Feb 28, 2008	Substantially Equivalent	Musculoskeletal Transplant Foundation
K063685	OPTECURE; OPTECURE + CCC	Jun 07, 2007	Substantially Equivalent	Exactech, Inc.
K063676	DBX DEMINERALIZED BONE MATRIX MIX	Mar 05, 2007	Substantially Equivalent	Musculoskeletal Transplant Foundation
K061131	DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY	Feb 08, 2007	Substantially Equivalent	Orthocon, Inc.
K061982	PLEXUR P	Feb 07, 2007	Substantially Equivalent	Osteotech, Inc.
K062205	DBX STRIP	Feb 05, 2007	Substantially Equivalent	Musculoskeletal Transplant Foundation
K060794	PROGENIX DBM PUTTY AND PASTE	Dec 18, 2006	Substantially Equivalent	Medtronic Sofamor Danek
K061668	OPTECURE +CCC	Sep 12, 2006	Substantially Equivalent	Exactech, Inc.
K060180	BIOSET XC	Sep 06, 2006	Substantially Equivalent	Regeneration Technologies, Inc.
K060161	AFT ALLOGRAFT FILLER TUBE	Mar 21, 2006	Substantially Equivalent	Musculoskeletal Transplant Foundation
K050806	OPTECURE	Feb 08, 2006	Substantially Equivalent	Exactech, Inc.
K053642	OSTEOSET DBM PELLETS	Jan 26, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K042829	DBX STRIP	Jan 13, 2006	Substantially Equivalent	Musculoskeletal Transplant Foundation
K052735	ALLOCRAFT DBM	Dec 28, 2005	Substantially Equivalent	Lifecell Corp.
K051195	GRAFTON DBM	Dec 16, 2005	Substantially Equivalent	Osteotech, Inc.
K050642	ORTHOBLAST II PUTTY AND PASTE	Dec 05, 2005	Substantially Equivalent	Isotis Orthobiologics, Inc.
K043209	VIAGRAF DBM PASTE	Dec 05, 2005	Substantially Equivalent	Osteotech, Inc.
K053098	OPTIUM DBM GEL AND PUTTY	Nov 28, 2005	Substantially Equivalent	Lifenet
K043048	GRAFTON PLUS DBM PASTE	Nov 23, 2005	Substantially Equivalent	Osteotech, Inc.