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

Osteoimplant Technology, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
168 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDOsteoimplant Technology, Inc.2005-01-253150
K041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMOsteoimplant Technology, Inc.2004-11-161680
K040225OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMOsteoimplant Technology, Inc.2004-05-06940
K032729Z-SERIES MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.2003-12-03910
K030608OTI BONE CEMENT PLUGOsteoimplant Technology, Inc.2003-06-121066
K022779OTI UNICONDULAR INTERPOSITIONAL SPACEROsteoimplant Technology, Inc.2002-11-20900
K021822R120 MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.2002-07-23490
K012762MJS POSTERIOR STABILIZED KNEE SYSTEMOsteoimplant Technology, Inc.2001-12-111160
K011774R120 MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.2001-09-05900
K003316OTI CERAMIC FEMORAL HEAD SYSTEMOsteoimplant Technology, Inc.2001-01-19880
K003199TRIAD II MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.2001-01-10900
K000817OMEGA II MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.2000-06-08875
K984227OMEGA II MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.1999-04-081340
K990003J-SERIES OMEGA TOTAL HIP SYSTEMOsteoimplant Technology, Inc.1999-02-24510
K982886OTI MODULAR SHOULDER SYSTEMOsteoimplant Technology, Inc.1998-10-05490
K982598OTI FEMORAL LOCK TOTAL HIP SYSTEMOsteoimplant Technology, Inc.1998-10-02700
K980981OMEGA HA COATED TOTAL HIP SYSTEMOsteoimplant Technology, Inc.1998-05-20640
K974506LSF HA COATED TRIAD TOTAL HIP SYSTEMOsteoimplant Technology, Inc.1998-02-27880
K971020LSF TRIAD TOTAL HIP SYSTEMOsteoimplant Technology, Inc.1997-06-18900
K964924OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTOsteoimplant Technology, Inc.1997-03-07880
K960647OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONSOsteoimplant Technology, Inc.1996-09-172150

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