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

LZK — Predicate Candidate Screening

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

68 daysmedian FDA review time

113 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021419	AART MALAR IMPLANT	Aesthetic and Reconstructive Technologies, Inc.	2002-07-02	60	1
K002886	IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL	Implantech Associates, Inc.	2000-11-24	70	0
K992240	PILLAR MALAR IMPLANT	Pillar Surgical, Inc.	1999-11-22	143	0
K983756	SURGIFORM ANATOMICAL MALAR	Surgical Technology Laboratories, Inc.	1998-11-20	29	0
K982763	SEARE BIOMEDICAL MALAR IMPLANTS	Seare Biomedical Corp.	1998-09-30	55	0
K981835	SILIMED MALAR IMPLANT	Silimed, LLC	1998-07-09	44	0
K980139	SPECTRUM DESIGNS PROFILE MALAR IMPLANT	Spectrum Designs, Inc.	1998-03-03	47	0
K980141	SPECTRUM DESIGNS PROJECTION MALAR IMPLANT	Spectrum Designs, Inc.	1998-03-03	47	0
K980140	SPECTRUM DESIGNS MEDIAL MALAR IMPLANT	Spectrum Designs, Inc.	1998-03-03	47	0
K973502	IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT	Implantech Associates, Inc.	1997-11-07	52	0
K973574	DURALASTIC ANATOMICAL MALAR IMPLANT	Hanson Medical, Inc.	1997-10-24	35	0
K971479	DURALASTIC ANATOMICAL MALAR IMPLANTS	Allied Biomedical Corp.	1997-07-18	86	0
K970400	BONE SOURCE HYDROXYAPATITE	Orthofix, Inc.	1997-05-02	88	0
K964443	SURGIFORM ANATOMICAL MALAR	Surgical Technology Laboratories, Inc.	1996-12-20	44	0
K962261	IMPLANTECH WM NASAL-LABIAL IMPLANT	Implantech Associates, Inc.	1996-08-19	68	0
K961511	HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER	Lifecore Biomedical, Inc.	1996-06-28	70	0
K961210	SAM FACIAL IMPLANT	W. L. Gore & Associates, Inc.	1996-06-19	83	0
K961080	MEDIAL MALAR IMPLANT	Rand Scientific Corp.	1996-04-19	32	0
K960362	PERMAMESH HYDROXYLAPATITE MATRIX	Ceramed Corp.	1996-03-20	55	0
K960354	PERMAMESH-D HYDROXYLAPATITE MATRIX	Ceramed Corp.	1996-03-20	55	0
K943988	IMPLANTECH NASAL LABIAL IMPLANT	Implantech Associates, Inc.	1995-01-27	164	0
K944165	SILHOUETTE MALAR IMPLANT	Spectrum Designs, Inc.	1994-11-04	70	1
K944166	DORSAL COLUMELLA IMPLANT	Spectrum Designs, Inc.	1994-11-04	70	0
K944164	MENISCUS CHIN IMPLANT	Spectrum Designs, Inc.	1994-11-04	70	0
K942421	IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT	King & Spalding	1994-08-08	80	0
K942420	IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT	King & Spalding	1994-08-08	80	0
K934233	ZARA ZONE IV MALAR IMPLANT MODIFICATION	Byron Medical	1994-02-03	157	0
K921582	FLOWERS MEDIAL MALAR IMPLANT	Implantech Associates, Inc.	1992-05-06	34	0
K914016	ZARA ZONE IV MALAR IMPLANT	Byron Medical	1991-12-05	87	0
K911515	EXTENDED MALAR IMPLANT	Implantech Associates, Inc.	1991-07-01	88	0
K911513	TRAPEZOIDAL MALAR IMPLANT	Implantech Associates, Inc.	1991-07-01	88	0
K910655	COMBINED MALAR IMPLANT	Implantech Associates, Inc.	1991-03-28	42	0
K904348	CUI FEATHERED SILICONE MALAR	Cui Corp.	1990-11-26	63	0
K902284	ZYMALAR IMPLANT	Applied Biomaterial Technologies	1990-09-12	113	0
K903329	CUI ANATOMICAL SILICONE MALAR	Cui Corp.	1990-09-10	47	0
K901662	ANATOMICAL MALAR IMPLANT	Implantech Associates, Inc.	1990-05-01	21	0
K894493	BINDER SUBMALAR FACIAL IMPLANT	Implantech Associates, Inc.	1989-10-27	100	0
K895152	BINDER SUBMALAR FACIAL IMPLANT II	Implantech Associates, Inc.	1989-10-27	78	0
K873434	CREAT BRAND MALAR IMPLANT	Aesthetech Corp.	1987-09-11	16	0
K863400	BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR	Byron Medical	1986-09-17	14	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