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

Macropore Biosurgery, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
274 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042261MACROPORE PURICEL LIPOPLASTY SYSTEMMacropore Biosurgery, Inc.2004-09-20280
K041105MACROPORE HYDROSORB SPINE SYSTEMMacropore Biosurgery, Inc.2004-07-28890
K031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETMacropore Biosurgery, Inc.2003-09-22890
K031785MACROPORE CARDIO-WRAP (TS)Macropore Biosurgery, Inc.2003-09-04860
K024169MACROPORE OS RECONSTRUCTIONMacropore Biosurgery, Inc.2003-07-011950
K023643MACROPORE SURGICAL BARRIER FILMMacropore Biosurgery, Inc.2003-02-211140
K021164MACROPORE OS TRAUMAMacropore Biosurgery, Inc.2002-07-01810
K012025MACROPORE SURGIWRAP (TS)Macropore Biosurgery, Inc.2001-12-031580
K012769MACROPORE ENT RECONSTRUCTION FILMMacropore Biosurgery, Inc.2001-10-25690
K012413MACROPORE FX, PS, NS, LPMacropore Biosurgery, Inc.2001-09-18500
K011715MACROPORE IB RESORBABLE PLUGMacropore Biosurgery, Inc.2001-08-27840
K010911MACROPORE OS SPINAL SYSTEMMacropore Biosurgery, Inc.2001-07-201160
K002207MACROPOREPX PEDIATRIC SYSTEMMacropore Biosurgery, Inc.2001-07-113550
K002334MACROPORENS CRANILOCMacropore Biosurgery, Inc.2001-05-022740
K000696MACROPOREMX MANDIBULAR FIXATION SYSTEMMacropore Biosurgery, Inc.2000-10-192320
K994158MACROSORBOS PROTECTIVE SHEETMacropore Biosurgery, Inc.2000-07-242280
K000992MACROPOREDX DISTRACTOR SYSTEMMacropore Biosurgery, Inc.2000-06-26900

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