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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Rog Sports Medicine, Inc. · Predicate Candidate Screening

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

63 daysmedian FDA review time
113 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113299ROG SUTURE ANCHORRog Sports Medicine, Inc.2011-12-15370
K112991MODIFIED ROG SUTURE ANCHORRog Sports Medicine, Inc.2011-12-08630
K111590ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHORRog Sports Medicine, Inc.2011-08-08620
K110230ROG KNOTLESS SUTURE ANCHORRog Sports Medicine, Inc.2011-05-191130
K110229ROG SUTURE ANCHOR 5.5MM, 2.9MMRog Sports Medicine, Inc.2011-05-181120

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