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

Metasurg — Predicate Candidate Screening

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

82 daysmedian FDA review time
134 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123926METASURG NITINOL STAPLE IMPLANTMetasurg2013-05-031340
K111265METASURG SUBTALAR IMPLANTMetasurg2011-08-09970
K111536METASURG DIGIFUSE IMPLANTMetasurg2011-07-21490
K083469METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000Metasurg2009-02-13810
K070441METASURG SUBTALAR IMPLANTMetasurg2007-05-08820

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