Atlas FDA

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

Osteomed — Predicate Candidate Screening

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

140 daysmedian FDA review time
246 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed2021-02-24890
K162542OsteoMed PINNACLE DriverOsteomed2017-05-192490
K162544OsteoMed PINNACLE DriverOsteomed2017-04-042040
K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed2016-05-19360
K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed2015-12-211400
K151195OsteoMed IMF ScrewOsteomed2015-09-211400
K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEMOsteomed2014-12-182460
K140283OSTEOMED EXTREMIFUSE SYSTEMOsteomed2014-02-28240
K131851OSTEOMED NEURO RONGEUROsteomed2013-12-061680
K1334371ST MTP PLATEOsteomed2013-12-02250
K130412OSTEOMED EXTREMIFUSE SYSTEMOsteomed2013-05-311010
K121304OSTEOMED CRANIAL DISTRACTION SYSTEMOsteomed2012-08-221130

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