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

LZN — Predicate Candidate Screening

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

72 daysmedian FDA review time

392 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220838	Artisan Bone Plug, Universal Cement Restrictor	Howmedica Osteonics, Dba Stryker Orthopaedics	2022-05-20	59	0
K061824	TORNIER CEMENT RESTRICTOR	Tornier	2006-09-14	78	0
K032685	CEMSTOP CEMENT RESTRICTOR	Teknimed, S.A.	2003-11-26	89	0
K023680	BIOBUCK CEMENT RESTRICTOR	Smith & Nephew, Inc.	2002-11-19	18	0
K011943	IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR	Kensey Nash Corp.	2001-09-19	90	0
K010840	SYNPLUG	Isotis NV	2001-04-20	30	0
K993841	CEMSTOP CEMENT RESTRICTOR	Encore Orthopedics, Inc.	2000-05-04	174	0
K000587	SHUTTLE STOP	Isotis NV	2000-05-04	72	0
K992462	OSTEONICS UNIVERSAL DISTAL CEMENT PLUG	Howmedica Osteonics Corp.	1999-08-13	21	0
K972411	LINK CEMENT PLUG	Turnkey Intergration USA, Inc.	1997-08-29	64	0
K970779	OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS	Osteonics Corp.	1997-05-09	66	0
K955632	ORTHOPLUG SOFT BONE DESIGN	Sunmed, Inc.	1996-02-27	78	0
K955631	ORTHOPLUG HARD BONE DESIGN	Sunmed, Inc.	1996-02-27	78	0
K955751	PRIME FEMORAL CEMENT PLUG	Orthopaedic Innovations, Inc.	1996-01-26	37	0
K951930	CEMENTRALIZER DISTAL STEM CENTRALIZER	Depuy, Inc.	1995-07-11	97	0
K951934	PFC CEMENT RESTRICTOR	Johnson & Johnson Professionals, Inc.	1995-05-16	21	0
K951860	HOWMEDICE BONE PLUG	Howmedica Corp.	1995-05-16	25	0
K933077	EXETER INTRAMEDULLARY BONE PLUG	Howmedica Corp.	1995-05-16	692	0
K943727	BIOSTOP G BONE CEMENT RESTRICTOR	Landos, Inc.	1995-05-11	282	1
K943378	IMPLEX CEMENT RESTRICTOR SYSTEM	Implex Corp.	1994-09-23	72	0
K942060	P.F.C. CEMENT RESTRICTOR	Johnson & Johnson Professionals, Inc.	1994-09-20	144	0
K932595	ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR	Johnson & Johnson Orthopaedics, Inc.	1994-09-20	480	0
K931847	BIO-PREP CEMENT RESTRICTOR	Biomedical Devices, Inc.	1994-06-28	441	7
K931540	UNIVERSAL BONE CEMENT KIT	Biodynamic Technologies, Inc.	1994-01-27	304	0
K920118	RESORABPLUG	Sofamor Danek Mfg., Inc.	1993-02-08	392	0
K923909	CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL	Orthomet, Inc.	1992-11-04	92	0
K911717	ADG INTRAMEDULLARY BONE PLUG - VENTED	American Design Group, Inc.	1991-09-04	140	0
K910135	THE UNIVERSAL CEMENT PLUG(TM)	Biotron , Ltd.	1991-03-05	55	0
K902615	ADG BONE PLUG	American Design Group, Inc.	1990-09-11	90	0
K900392	CENTERING PLUG	Allo Pro Corp.	1990-03-01	34	0
K890326	HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG	Howmedica Corp.	1989-02-03	11	0
K853186	SILASTIC INFLATABLE BONE PLUG H.P.	Dow Corning Corp. Healthcare Industries Materials	1985-09-24	56	0
K852449	HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER	Howmedica Corp.	1985-08-12	63	0
K830949	POLYETHYLENE MEDULLARY PLUG - STIIHMER/	Allo Pro Corp.	1983-04-12	19	0
K810353	HARRIS CEMENT RESTRICTOR	Cintor Orthopaedic Div.	1981-02-23	13	0
K791125	PLUG-LOK CEMENT RESTIRCTOR	Richard'S Medical Equip., Inc.	1979-06-27	9	0
K771408	WROUGHT (FORGED) VITALLIUM	Howmedica Corp.	1977-08-04	6	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