Atlas FDA

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

Isotis NV — Predicate Candidate Screening

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

72 daysmedian FDA review time
435 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15Isotis NV2007-08-154080
K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYIsotis NV2006-03-29480
K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYIsotis NV2006-03-27480
K031813OSSATURA DENTALIsotis NV2004-08-204350
K041344OPEN BORE SYRINGEIsotis NV2004-07-16570
K030131OSSATURA BCP BONE VOID FILLERIsotis NV2003-05-201260
K010840SYNPLUGIsotis NV2001-04-20300
K000587SHUTTLE STOPIsotis NV2000-05-04720

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