Atlas FDA

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

Synthes, Inc. — Predicate Candidate Screening

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

181 daysmedian FDA review time
353 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131792SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYSynthes, Inc.2013-12-161810
K122647SYNTHES PATIENT SPECIFIC PLATESynthes, Inc.2013-02-281820
K113567SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSynthes, Inc.2012-11-193530
K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, Inc.2012-08-23940
K121574SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSynthes, Inc.2012-06-29300
K113251SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATESSynthes, Inc.2011-12-21480
K111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLSynthes, Inc.2011-11-161890
K112689SYNTHES STERNAL FIXATION SYSTEMSynthes, Inc.2011-10-26410

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