Atlas FDA

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

NUN — Predicate Candidate Screening

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

118 daysmedian FDA review time
426 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130235SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PHans Biomed Corp.2014-01-103450
K113645REGENEROSS ALLOGRAFT PLUS MINERLIZEDBiomet Interpore Cross2012-01-20390
K103699EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCExactech, Inc.2011-08-122350
K091217DBX DEMINERALIZED BONE MATRIX PUTTYMusculoskeletal Transplant Foundation2009-10-021580
K082463PROGENIXMedtronic Sofamor Danek2008-11-10750
K081950PROGENIX PLUSMedtronic Sofamor Danek, Inc.2008-07-1890
K080462PROGENIX DBM PUTTYMedtronic Sofamor Danek2008-05-13830
K080418REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTRegeneration Technologies, Inc.2008-04-30750
K070147INTERGRO ORALBiomet 3i2007-05-141180
K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYIsotis NV2006-03-29480
K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYIsotis NV2006-03-27480
K051188GRAFTON DBMOsteotech, Inc.2006-01-0323813
K042707GRAFTON PLUS DBM PASTEOsteotech, Inc.2005-11-3042612
K043573DYNAGRAFT II DENTALIsotis Orthobiologics, Inc.2005-07-292140
K040501DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIXMusculoskeletal Transplant Foundation2005-04-294280

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