Atlas FDA

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

MBV — Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

64 daysmedian FDA review time
165 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K010212OFFSET TIBIAL TRAYBiomet, Inc.2001-02-14223
K884824TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.1989-11-213680
K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.1987-10-28640
K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.1986-02-181650
K833200TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.1983-11-29710
K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.1983-09-011190
K832302MARK I TOTAL KNEE SYS. ARTHROPLASTYAdvanced Biosearch Assn.1983-08-16330
K830726MARK I & II TOTAL KNEE REPLACE. SYSAdvanced Biosearch Assn.1983-06-221060
K823837RMC TOTAL KNEE SYSTEMRichard'S Medical Equip., Inc.1983-03-29980
K830408FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.1983-02-24170
K822583TOTAL KNEE SYSTEMRichard'S Medical Equip., Inc.1982-10-04390
K802921ICLH TIBIAL PLATEAUDepuy, Inc.1981-01-08510
K780904KNEE, TOTAL, FEMORAL & TIBIALDepuy, Inc.1978-06-22230
K780284TIBIAL PLATEUDepuy, Inc.1978-03-15220

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