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

Orthomatrix, Inc. — Predicate Candidate Screening

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

142 daysmedian FDA review time
238 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K010738CANNULATED PLUS SCREW SYSTEMOrthomatrix, Inc.2001-08-011420
K001254ORTHOMATRIX, INC. CERCLAGE SYSTEMOrthomatrix, Inc.2000-12-132380
K992850MAGELLAN TIBIAL INTRAMEDULLARY NAILOrthomatrix, Inc.2000-03-101990
K992856MAGELLAN HUMERAL INTRAMEDULLARY NAILOrthomatrix, Inc.2000-03-101990
K852766HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTIOrthomatrix, Inc.1985-10-211150
K852765HA-2000 HYDROXYLAPATITEOrthomatrix, Inc.1985-09-23870
K851367HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATIONOrthomatrix, Inc.1985-05-21460
K842163RIDGEMATRIX 20/40 MESH, PERIOMATRIXOrthomatrix, Inc.1984-08-09710

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