Atlas FDA

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

Osteo Technology, Inc. — Predicate Candidate Screening

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

253 daysmedian FDA review time
457 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K926156REPLICA(TM) TOTAL HIP SYSTEMOsteo Technology, Inc.1994-03-094570
K922859ANATOMICAL TYPE KNEE SYSTEMOsteo Technology, Inc.1993-09-234760
K922869TOTAL CONDYLAT TYPE KNEE SYSTEMOsteo Technology, Inc.1993-07-134040
K925447OTI ORTHOPEDIC WIRE SYSTEMOsteo Technology, Inc.1993-06-292440
K926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEMOsteo Technology, Inc.1993-06-171890
K922861BIOMETRIC SCREW FIXATION CUPOsteo Technology, Inc.1993-05-123420
K922870THREE SPIKE CUPOsteo Technology, Inc.1993-04-083080
K925301OTI ORTHOPEDIC FASTENER SYSTEMOsteo Technology, Inc.1993-03-161460
K922682AMERICANA HIP PROTHESISOsteo Technology, Inc.1993-03-162850
K922862CHARNLEY TYPE HIP PROTHESISOsteo Technology, Inc.1993-02-122530
K922860AUSTIN-MOORE TYPE HIP PROSTHESISOsteo Technology, Inc.1993-02-122530
K922868THOMPSON TYPE HIP PROTHESISOsteo Technology, Inc.1993-02-122530
K922871UNIFIT FEMORAL STEMOsteo Technology, Inc.1993-02-122530
K922863EUROSTEM HIP PROTHESIS SYSTEMOsteo Technology, Inc.1993-02-122530
K922864MUELLER TYPE FEMORAL STEMOsteo Technology, Inc.1993-02-122530
K922866OTI BONE PLUGOsteo Technology, Inc.1993-02-122530
K922645LSF ANATOMIC CEMENTED HIPOsteo Technology, Inc.1993-01-072180
K922865NEER TYPE SHOULDER PROSTHESIS SYSTEMOsteo Technology, Inc.1992-12-101890

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