Product Code: LZN FDA class 2 21 CFR 878.3300

Cement Obturator

General, Plastic Surgery

The Cement Obturator (product code LZN) is an orthopedic implant accessory used to seal or block the intramedullary canal with bone cement during joint replacement surgery, ensuring proper cement pressurization and distribution for implant fixation. Regulated under 21 CFR 878.3300 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant given its placement within the bone canal. The device falls under the General and Plastic Surgery specialty with review by the Orthopedic (OR) panel. It is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LZN
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220838	Artisan Bone Plug, Universal Cement Restrictor	May 20, 2022	Substantially Equivalent	Howmedica Osteonics, Dba Stryker Orthopaedics
K061824	TORNIER CEMENT RESTRICTOR	Sep 14, 2006	Substantially Equivalent	Tornier
K032685	CEMSTOP CEMENT RESTRICTOR	Nov 26, 2003	Substantially Equivalent	Teknimed, S.A.
K023680	BIOBUCK CEMENT RESTRICTOR	Nov 19, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K011943	IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR	Sep 19, 2001	Substantially Equivalent	Kensey Nash Corp.
K010840	SYNPLUG	Apr 20, 2001	Substantially Equivalent	Isotis NV
K993841	CEMSTOP CEMENT RESTRICTOR	May 04, 2000	Substantially Equivalent	Encore Orthopedics, Inc.
K000587	SHUTTLE STOP	May 04, 2000	Substantially Equivalent	Isotis NV
K992462	OSTEONICS UNIVERSAL DISTAL CEMENT PLUG	Aug 13, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K972411	LINK CEMENT PLUG	Aug 29, 1997	Substantially Equivalent	Turnkey Intergration USA, Inc.
K970779	OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS	May 09, 1997	Substantially Equivalent	Osteonics Corp.
K955632	ORTHOPLUG SOFT BONE DESIGN	Feb 27, 1996	Substantially Equivalent	Sunmed, Inc.
K955631	ORTHOPLUG HARD BONE DESIGN	Feb 27, 1996	Substantially Equivalent	Sunmed, Inc.
K955751	PRIME FEMORAL CEMENT PLUG	Jan 26, 1996	Substantially Equivalent	Orthopaedic Innovations, Inc.
K951930	CEMENTRALIZER DISTAL STEM CENTRALIZER	Jul 11, 1995	Substantially Equivalent	Depuy, Inc.
K951934	PFC CEMENT RESTRICTOR	May 16, 1995	Substantially Equivalent for Some Indications	Johnson & Johnson Professionals, Inc.
K951860	HOWMEDICE BONE PLUG	May 16, 1995	Substantially Equivalent for Some Indications	Howmedica Corp.
K933077	EXETER INTRAMEDULLARY BONE PLUG	May 16, 1995	Substantially Equivalent for Some Indications	Howmedica Corp.
K943727	BIOSTOP G BONE CEMENT RESTRICTOR	May 11, 1995	Substantially Equivalent	Landos, Inc.
K943378	IMPLEX CEMENT RESTRICTOR SYSTEM	Sep 23, 1994	Substantially Equivalent	Implex Corp.
K942060	P.F.C. CEMENT RESTRICTOR	Sep 20, 1994	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K932595	ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR	Sep 20, 1994	Substantially Equivalent	Johnson & Johnson Orthopaedics, Inc.
K931847	BIO-PREP CEMENT RESTRICTOR	Jun 28, 1994	Substantially Equivalent	Biomedical Devices, Inc.
K931540	UNIVERSAL BONE CEMENT KIT	Jan 27, 1994	Substantially Equivalent	Biodynamic Technologies, Inc.
K920118	RESORABPLUG	Feb 08, 1993	Substantially Equivalent	Sofamor Danek Mfg., Inc.
K923909	CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL	Nov 04, 1992	Substantially Equivalent	Orthomet, Inc.
K911717	ADG INTRAMEDULLARY BONE PLUG - VENTED	Sep 04, 1991	Substantially Equivalent	American Design Group, Inc.
K910135	THE UNIVERSAL CEMENT PLUG(TM)	Mar 05, 1991	Substantially Equivalent	Biotron , Ltd.
K902615	ADG BONE PLUG	Sep 11, 1990	Substantially Equivalent	American Design Group, Inc.
K900392	CENTERING PLUG	Mar 01, 1990	Substantially Equivalent	Allo Pro Corp.
K890326	HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG	Feb 03, 1989	Substantially Equivalent	Howmedica Corp.
K853186	SILASTIC INFLATABLE BONE PLUG H.P.	Sep 24, 1985	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K852449	HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER	Aug 12, 1985	Substantially Equivalent	Howmedica Corp.
K830949	POLYETHYLENE MEDULLARY PLUG - STIIHMER/	Apr 12, 1983	Substantially Equivalent	Allo Pro Corp.
K810353	HARRIS CEMENT RESTRICTOR	Feb 23, 1981	Substantially Equivalent	Cintor Orthopaedic Div.
K791125	PLUG-LOK CEMENT RESTIRCTOR	Jun 27, 1979	Substantially Equivalent	Richard'S Medical Equip., Inc.
K771408	WROUGHT (FORGED) VITALLIUM	Aug 04, 1977	Substantially Equivalent	Howmedica Corp.