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

Regeneration Technologies, Inc. — Predicate Candidate Screening

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

75 daysmedian FDA review time

165 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K080418	REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORT	Regeneration Technologies, Inc.	2008-04-30	75	0
K072238	BIOSET XCH	Regeneration Technologies, Inc.	2008-01-25	165	0
K072327	CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON	Regeneration Technologies, Inc.	2007-10-24	65	0
K063584	STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-P	Regeneration Technologies, Inc.	2007-05-09	159	0
K060180	BIOSET XC	Regeneration Technologies, Inc.	2006-09-06	226	0
K060253	STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW	Regeneration Technologies, Inc.	2006-02-23	22	0
K052405	STERLING INTERFERENC SCREW HT	Regeneration Technologies, Inc.	2005-11-16	76	0
K051615	STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES	Regeneration Technologies, Inc.	2005-08-15	59	0
K050767	STERLING INTERFERENCE SCREW ST	Regeneration Technologies, Inc.	2005-06-09	76	0
K043421	OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT ST	Regeneration Technologies, Inc.	2005-02-16	65	9
K043420	OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE	Regeneration Technologies, Inc.	2005-02-10	59	13

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