Atlas FDA

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

Orthopedic Sciences, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time
154 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133018OSI Q SYSTEM ARTHROSCOPESOrthopedic Sciences, Inc.2014-02-261540
K091398ARTHROSCOPEOrthopedic Sciences, Inc.2009-08-261060
K072175TITANIUM HIP TOOL LOCKING PLATEOrthopedic Sciences, Inc.2007-08-21150
K063709TS-BONE HIP TOOLOrthopedic Sciences, Inc.2007-01-04210
K063033MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANTOrthopedic Sciences, Inc.2006-11-01290
K052538S-BONE HIP TOOLOrthopedic Sciences, Inc.2005-10-07220
K051181CUSTOM-HIP TOOLOrthopedic Sciences, Inc.2005-05-23140
K051032TITANIUM-HIP TOOLOrthopedic Sciences, Inc.2005-05-23310
K040493OUTOLOGOUS SPINAL FIXATION SYSTEMOrthopedic Sciences, Inc.2004-09-031900
K040850TSY SHOULDER PLATE IMPLANTOrthopedic Sciences, Inc.2004-06-24850
K022139HIP TOOL IMPLANTOrthopedic Sciences, Inc.2002-09-23830

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