Product Code: JDK FDA class 2 21 CFR 878.3300

Prosthesis, Hip, Cement Restrictor

General, Plastic Surgery

A hip prosthesis cement restrictor is an implantable plug placed within the femoral canal to prevent bone cement from migrating distally during hip arthroplasty, ensuring adequate cement pressurization and optimal interdigitation with the surrounding cancellous bone. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JDK, regulated under 21 CFR 878.3300, within the General and Plastic Surgery medical specialty. This device is an implant.

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FEI Numbers

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Basic Information

Product Code: JDK
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

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 54 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K210062	Mectaplug PE II	Apr 08, 2021	Substantially Equivalent	Medacta International S.A.
K061465	KMI CEMENT RESTRICTOR IMPLANT	Oct 05, 2006	Unknown	Kinetikos Medical, Inc.
K061698	MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR	Jul 12, 2006	Substantially Equivalent	Life Spine
K060247	LIFE SPINE CEMENT RESTRICTOR	May 11, 2006	Unknown	Life Spine
K060132	SPINAL USA CEMENT RESTRICTOR SYSTEM	Mar 16, 2006	Substantially Equivalent	Spinal USA
K051371	INTERBODY INNOVATIONS CEMENT RESTRICTOR	Dec 06, 2005	Unknown	Interbody Innovations, Llp
K051836	SKELITE RESORBABLE CEMENT RESTRICTOR	Nov 21, 2005	Unknown	Millenium Biologix, Inc.
K051607	NOVASPINE CEMENT RESTRICTOR NSCR	Oct 07, 2005	Substantially Equivalent	Novaspine, LLC
K052367	SCIENT'X CEMENT RESTRICTOR	Oct 05, 2005	Unknown	Scient'X
K041382	POLYGRAFT BGS; BONE GRAFT SUBSTITUTE	Jun 17, 2005	Unknown	Osteobiologics, Inc.
K050699	MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004	Apr 15, 2005	Substantially Equivalent	Amedica Corp.
K041583	PEEK CEMENT RESTRICTOR X-BOX	Jul 22, 2004	Unknown	Innovasis, Inc.
K033953	OPTIMESH 500E CEMENT RESTRICTOR	Jul 06, 2004	Unknown	Spineology, Inc.
K040276	QUANTUM CEMENT RESTRICTOR	Apr 30, 2004	Substantially Equivalent	Quantum Orthopedics
K030871	FIDJI LARGE CEMENT RESTRICTOR	Dec 22, 2003	Unknown	Spine Next SA
K030767	FIDJI SMALL CEMENT RESTRICTOR	Dec 22, 2003	Unknown	Spine Next SA
K033384	THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ	Nov 19, 2003	Substantially Equivalent	Implex Corp.
K032180	NUVASIVE CEMENT RESTRICTOR	Oct 07, 2003	Unknown	Nuvasive, Inc.
K031318	TRAXIS CEMENT RESTRICTOR	Aug 22, 2003	Unknown	Spinal Concepts, Inc.
K032095	INTERPORE CROSS CEMENT RESTRICTOR	Aug 08, 2003	Substantially Equivalent	Interpore Cross Intl.
K031837	MODIFICATION TO FORTITUDE CEMENT RESTRICTOR	Jul 24, 2003	Substantially Equivalent	Spinal Concepts, Inc.
K030608	OTI BONE CEMENT PLUG	Jun 12, 2003	Unknown	Osteoimplant Technology, Inc.
K023908	INTERPORE CROSS CEMENT RESTRICTOR	May 16, 2003	Unknown	Interpore Cross Intl.
K023647	CADENCE PEEK CEMEENT RESTRICTOR	Nov 27, 2002	Substantially Equivalent	Spinal Concepts, Inc.
K022615	CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR	Oct 29, 2002	Unknown	Centerpulse Spine-Tech, Inc.
K021788	NBD CEMENT RESTRICTOR DEVICE	Oct 04, 2002	Unknown	New Business Development, LLC
K021765	CEMENT RESTRICTOR, SMALL AND LARGE	Aug 16, 2002	Substantially Equivalent	Exactech, Inc.
K021719	FORTITUDE CEMENT RESTRICTOR	Aug 15, 2002	Unknown	Spinal Concepts, Inc.
K022218	CADENCE CEMENT RESTRICTOR	Aug 12, 2002	Substantially Equivalent	Spinal Concepts, Inc.
K020836	RABEA CEMENT RESTRICTOR	Jun 11, 2002	Substantially Equivalent	Signus Medical, LLC
K020344	RPX TITANIUM CEMNT RESTRICTOR	May 02, 2002	Substantially Equivalent	Sulzer Spine-Tech
K013663	CEMENT RESTRICTOR	Dec 05, 2001	Unknown	Medtronic Sofamor Danek, Inc.
K012462	THEKEN LARGE CEMENT RESTRICTOR	Oct 29, 2001	Unknown	Theken Surgical,Llc
K012278	THEKEN SMALL CEMENT RESTRICTOR	Oct 17, 2001	Unknown	Theken Surgical,Llc
K010528	TITANIUM CEMENT RESTRICTOR MATERIAL PEEK	Oct 10, 2001	Unknown	Medtronic Sofamor Danek USA, Inc.
K013014	BLOCK CEMENT RESTRICTOR (CR) - TITANIUM	Oct 04, 2001	Unknown	Medtronic Sofamor Danek, Inc.
K011443	THREADED CEMENT RESTRICTOR (CR) TITANIUM	Aug 03, 2001	Unknown	Medtronic Sofamor Danek USA, Inc.
K012255	MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR	Aug 01, 2001	Unknown	Medtronic Sofamor Danek, Inc.
K011998	METRONIC SOFAMOR DANEK CEMENT RESTRICTOR	Jul 26, 2001	Unknown	Medtronic Sofamor Danek, Inc.
K003718	TITANIUM CEMENT RESTRICTOR (TCR)	Feb 14, 2001	Unknown	Medtronic Sofamor Danek, Inc.
K990345	RABEA DEVICE, MODEL PXXXXXX	Jul 30, 1999	Unknown	Signus Medizintechnik GmbH
K965056	OSTEONICS SCREW HOLE PLUGS	Feb 28, 1997	Substantially Equivalent	Osteonics Corp.
K926216	BONE CEMENT RESTRICTOR	Mar 22, 1994	Substantially Equivalent	Biodynamic Technologies, Inc.
K923616	OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR	Oct 30, 1992	Substantially Equivalent	Osteonics Corp.
K911338	LIMA CEMENT RESTRICTOR	Jun 28, 1991	Substantially Equivalent	Turnkey Intergration USA, Inc.
K910461	OSTEONICS(R) MID-SHAFT CEMENT SPACER	Apr 08, 1991	Substantially Equivalent	Osteonics Corp.
K904746	S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER	Nov 20, 1990	Substantially Equivalent	Joint Medical Products Corp.
K900462	OSTEONICS CEMENT RESTRICTOR	Mar 06, 1990	Substantially Equivalent	Osteonics Corp.
K895378	PROXIMAL CEMENT SPACER	Nov 22, 1989	Substantially Equivalent	Osteonics Reconstructive Products Div.
K894708	PT DISTAL TIP CEMENT SPACER	Oct 10, 1989	Substantially Equivalent	Osteonics Corp.
K872528	OMNIFIT DISTAL STEM CEMENT SPACERS	Dec 29, 1987	Substantially Equivalent	Osteonics Corp.
K840413	CEMENT RESTRICTOR	Mar 05, 1984	Substantially Equivalent	American Ortomed Corp.
K831512	DOSIMETRY RELEASE OF RADIATION STERILIZ	Sep 29, 1983	Substantially Equivalent	Biomet, Inc.
K831128	BARD INTRAMEDULLARY PLUG	Jul 12, 1983	Substantially Equivalent	C.R. Bard, Inc.