Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HPZ — Predicate Candidate Screening

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

98 daysmedian FDA review time

287 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212741	EZYPOR	Fci (France Chirurgie Instrumentation) Sas	2022-06-24	298	0
K123764	DURETTE OCULAR IMPLANT	Oculo-Plastik, Inc.	2013-01-31	55	0
K110554	BIOCERAMIC ORBITAL IMPLANT, ORBTEX	Ceramisys, Ltd.	2011-11-02	247	0
K112176	SILICONE SPHERES	Oculo Plastik, Inc.	2011-09-15	49	0
K083342	ORBITAL RECONSTRUCTIVE IMPLANT II	Evera Medical, Inc.	2009-03-12	120	0
K082850	EYE SPHERES	Product and Educational Services, LLC	2009-02-27	151	0
K073293	DURETTE IMPLANT	Oculo Plastik, Inc.	2008-03-19	117	0
K071335	MEDPOR ATTRACTOR IMPLANT	Porex Surgical, Inc.	2007-08-08	89	0
K070130	ORBITAL RECONSTRUCTIVE IMPLANT	Becker & Associates Consulting, Inc.	2007-04-19	93	0
K053298	ALPHASPHERE ORBITAL IMPLANT	Hydron Pty Limited	2006-05-09	165	0
K040851	MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM	Porex Surgical, Inc.	2004-07-16	107	0
K040689	EYE SPHERE IMPLANTS	Oculo Plastik, Inc.	2004-06-10	86	0
K023400	FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT	Fci Ophthalmics, Inc.	2003-08-22	317	0
K021643	HA ORBITAL IMPLANT	Laboratoire Villanova	2002-12-13	207	0
K021357	MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT	Porex Surgical, Inc.	2002-08-05	98	1
K010902	MEDPOR QUAD MOTILITY IMPLANT	Porex Surgical, Inc.	2001-06-19	85	0
K003338	BIO-EYE II ORBITAL IMPLANT	Integrated Orbital Implants, Inc.	2001-02-07	105	1
K992294	BIOCERAMIC ORBITAL IMPLANT	Fci Ophthalmics, Inc.	2000-04-19	287	0
K982562	BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER	Integrated Orbital Implants, Inc.	1998-12-28	158	2
K972143	MOA BONE / M-SPHERE	Iop, Inc.	1997-10-16	132	0
K972661	EYE SPHERE, CONFORMERS	Gulden Ophthalmics	1997-10-03	79	13
K962241	GORE SPHEREX IMPLANT	W. L. Gore & Associates, Inc.	1996-08-22	72	0
K960859	MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES	Porex Technologies Corp. of Georgia	1996-05-29	89	0
K954939	MEDPOR OCULAR SCREW & ACCESSORIES	Porex Surgical, Inc.	1996-01-25	87	0
K941717	MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT	Miguel Martinez M.D.	1995-02-14	313	0
K943275	MEDPOR SURGICAL IMPLANT MATERIAL	Porex Surgical, Inc.	1994-09-02	57	0
K934834	EPTFE SHEET COVERING FOR OCULAR IMPLANT	Oculo Plastik, Inc.	1994-05-05	209	0
K935251	MARTINEZ ORBITAL IMPLANT	Miguel Martinez M.D.	1994-03-01	120	0
K921106	STERILE/SINGLE USE EYE SPHERE IMPLANTS	Storz Instrument Co.	1992-03-30	21	0
K915630	OPHTIMPLANT	Oculo Plastik, Inc.	1992-03-02	76	0
K911110	OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS	G.W.B. Intl., Ltd.	1991-06-18	106	0
K900080	NEW IOWA MOTILITY IMPLANT	Oculo Plastik, Inc.	1990-03-23	78	0
K900081	NEW ALLEN IMPLANT	Oculo Plastik, Inc.	1990-03-23	78	0
K895908	MULES SPHERE GLASS (SEVERAL SIZES)	Ginsberg Scientific, Inc.	1990-01-08	90	0
K891137	MOTILITY ORBITAL IMPLANT	Integrated Orbital Implants, Inc.	1989-08-24	174	0
K873578	LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT	Oculo-Plastik Reg'D	1987-11-02	60	0
K863943	POREX(TM) EYE SPHERE IMPLANT	Porex Medical	1987-02-27	140	1
K862977	MEDITRADE ARTIFICIAL EYES AND IMPLANTS	Meditrade, Inc.	1986-10-20	74	0
K781356	IMPLANT, EYE SPHERE	Mcghan Medical Corp.	1978-08-21	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