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

Ceremed , Inc. — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

67 daysmedian FDA review time

133 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K161446	Biopor Porous Polyethylene Implants	Ceremed , Inc.	2016-09-27	125	0
K160988	Biopor, AOC Porous Polyethylene, Cerepor	Ceremed , Inc.	2016-07-14	97	0
K141880	BIOPOR AOC POROUS POLYETHYLENE, CEREPOR	Ceremed , Inc.	2015-04-16	279	0
K132198	ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI	Ceremed , Inc.	2013-09-12	58	0
K122561	ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN	Ceremed , Inc.	2012-11-27	97	0
K120220	ADAPTAIN SOLUBLE IMPLANT MATERIAL	Ceremed , Inc.	2012-06-06	133	0
K103047	CERETENE SOLUBLE IMPLANT MATERIAL	Ceremed , Inc.	2011-01-05	82	0
K102071	OSTENE CT, AOC CT, OSTEOTENE, CERETENE	Ceremed , Inc.	2010-10-08	77	0
K091636	OSTENE CT, AOC CT, OSTEOTENE, CERETENE	Ceremed , Inc.	2009-06-22	18	0
K082491	OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT,	Ceremed , Inc.	2008-09-24	27	0
K082245	AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AO	Ceremed , Inc.	2008-09-18	42	0
K081531	AOC SOLUBLE IMPLANT MATERIAL	Ceremed , Inc.	2008-07-18	46	0
K080507	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETH	Ceremed , Inc.	2008-04-21	56	0
K070093	OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE,	Ceremed , Inc.	2007-01-24	14	0
K062280	OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE A	Ceremed , Inc.	2006-12-11	126	0
K052528	AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE	Ceremed , Inc.	2005-10-11	27	0
K051293	CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS;	Ceremed , Inc.	2005-06-14	27	0
K050440	AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERET	Ceremed , Inc.	2005-03-24	30	0
K043133	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETH	Ceremed , Inc.	2005-03-02	110	0
K041363	AOC BONE WAX	Ceremed , Inc.	2004-07-27	67	1

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