Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

JDK — Predicate Candidate Screening

54 FDA 510(k) clearances under this product code; the 50 most recent screened below.

85 daysmedian FDA review time

197 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K210062	Mectaplug PE II	Medacta International S.A.	2021-04-08	87	0
K061465	KMI CEMENT RESTRICTOR IMPLANT	Kinetikos Medical, Inc.	2006-10-05	132	0
K061698	MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR	Life Spine	2006-07-12	26	0
K060247	LIFE SPINE CEMENT RESTRICTOR	Life Spine	2006-05-11	100	0
K060132	SPINAL USA CEMENT RESTRICTOR SYSTEM	Spinal USA	2006-03-16	57	0
K051371	INTERBODY INNOVATIONS CEMENT RESTRICTOR	Interbody Innovations, Llp	2005-12-06	194	0
K051836	SKELITE RESORBABLE CEMENT RESTRICTOR	Millenium Biologix, Inc.	2005-11-21	138	0
K051607	NOVASPINE CEMENT RESTRICTOR NSCR	Novaspine, LLC	2005-10-07	112	0
K052367	SCIENT'X CEMENT RESTRICTOR	Scient'X	2005-10-05	37	0
K041382	POLYGRAFT BGS; BONE GRAFT SUBSTITUTE	Osteobiologics, Inc.	2005-06-17	388	0
K050699	MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-0	Amedica Corp.	2005-04-15	28	0
K041583	PEEK CEMENT RESTRICTOR X-BOX	Innovasis, Inc.	2004-07-22	41	0
K033953	OPTIMESH 500E CEMENT RESTRICTOR	Spineology, Inc.	2004-07-06	197	0
K040276	QUANTUM CEMENT RESTRICTOR	Quantum Orthopedics	2004-04-30	85	0
K030871	FIDJI LARGE CEMENT RESTRICTOR	Spine Next SA	2003-12-22	278	0
K030767	FIDJI SMALL CEMENT RESTRICTOR	Spine Next SA	2003-12-22	286	0
K033384	THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 0	Implex Corp.	2003-11-19	27	0
K032180	NUVASIVE CEMENT RESTRICTOR	Nuvasive, Inc.	2003-10-07	82	0
K031318	TRAXIS CEMENT RESTRICTOR	Spinal Concepts, Inc.	2003-08-22	119	0
K032095	INTERPORE CROSS CEMENT RESTRICTOR	Interpore Cross Intl.	2003-08-08	31	0
K031837	MODIFICATION TO FORTITUDE CEMENT RESTRICTOR	Spinal Concepts, Inc.	2003-07-24	38	0
K030608	OTI BONE CEMENT PLUG	Osteoimplant Technology, Inc.	2003-06-12	106	6
K023908	INTERPORE CROSS CEMENT RESTRICTOR	Interpore Cross Intl.	2003-05-16	172	0
K023647	CADENCE PEEK CEMEENT RESTRICTOR	Spinal Concepts, Inc.	2002-11-27	28	0
K022615	CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR	Centerpulse Spine-Tech, Inc.	2002-10-29	83	0
K021788	NBD CEMENT RESTRICTOR DEVICE	New Business Development, LLC	2002-10-04	126	0
K021765	CEMENT RESTRICTOR, SMALL AND LARGE	Exactech, Inc.	2002-08-16	79	0
K021719	FORTITUDE CEMENT RESTRICTOR	Spinal Concepts, Inc.	2002-08-15	84	0
K022218	CADENCE CEMENT RESTRICTOR	Spinal Concepts, Inc.	2002-08-12	34	0
K020836	RABEA CEMENT RESTRICTOR	Signus Medical, LLC	2002-06-11	89	0
K020344	RPX TITANIUM CEMNT RESTRICTOR	Sulzer Spine-Tech	2002-05-02	90	0
K013663	CEMENT RESTRICTOR	Medtronic Sofamor Danek, Inc.	2001-12-05	29	0
K012462	THEKEN LARGE CEMENT RESTRICTOR	Theken Surgical,Llc	2001-10-29	89	0
K012278	THEKEN SMALL CEMENT RESTRICTOR	Theken Surgical,Llc	2001-10-17	90	0
K010528	TITANIUM CEMENT RESTRICTOR MATERIAL PEEK	Medtronic Sofamor Danek USA, Inc.	2001-10-10	229	0
K013014	BLOCK CEMENT RESTRICTOR (CR) - TITANIUM	Medtronic Sofamor Danek, Inc.	2001-10-04	27	0
K011443	THREADED CEMENT RESTRICTOR (CR) TITANIUM	Medtronic Sofamor Danek USA, Inc.	2001-08-03	84	0
K012255	MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR	Medtronic Sofamor Danek, Inc.	2001-08-01	14	0
K011998	METRONIC SOFAMOR DANEK CEMENT RESTRICTOR	Medtronic Sofamor Danek, Inc.	2001-07-26	29	0
K003718	TITANIUM CEMENT RESTRICTOR (TCR)	Medtronic Sofamor Danek, Inc.	2001-02-14	72	0
K990345	RABEA DEVICE, MODEL PXXXXXX	Signus Medizintechnik GmbH	1999-07-30	176	0
K965056	OSTEONICS SCREW HOLE PLUGS	Osteonics Corp.	1997-02-28	72	0
K926216	BONE CEMENT RESTRICTOR	Biodynamic Technologies, Inc.	1994-03-22	467	0
K923616	OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR	Osteonics Corp.	1992-10-30	101	0
K911338	LIMA CEMENT RESTRICTOR	Turnkey Intergration USA, Inc.	1991-06-28	94	0
K910461	OSTEONICS(R) MID-SHAFT CEMENT SPACER	Osteonics Corp.	1991-04-08	63	0
K904746	S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER	Joint Medical Products Corp.	1990-11-20	33	0
K900462	OSTEONICS CEMENT RESTRICTOR	Osteonics Corp.	1990-03-06	34	0
K895378	PROXIMAL CEMENT SPACER	Osteonics Reconstructive Products Div.	1989-11-22	84	0
K894708	PT DISTAL TIP CEMENT SPACER	Osteonics Corp.	1989-10-10	78	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda