Atlas FDA

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

Ortho Development Corporation — Predicate Candidate Screening

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

118 daysmedian FDA review time
253 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation2023-10-25290
K211086The Progen™ Trochanteric Nail SystemOrtho Development Corporation2021-12-212530
K211471Balanced Knee System UniOrtho Development Corporation2021-12-162190
K203023Pisces Spinal SystemOrtho Development Corporation2021-07-142850
K200281The Gecko Spinal SystemOrtho Development Corporation2020-03-31560
K182085Balanced Knee Revision System Trabecular Tibial Cone AugmentOrtho Development Corporation2018-10-31900
K181569BKS Revision Sleeves SystemOrtho Development Corporation2018-10-121200
K180743Balanced Knee Revision System - Offset Junction BoxOrtho Development Corporation2018-06-20900
K173951Legend Acetabular LinersOrtho Development Corporation2018-05-301540
K171249Entrada™ hip stemOrtho Development Corporation2017-08-241180
K162995Ibis® Pedicle Screw SystemOrtho Development Corporation2017-03-301540
K161080Escalade Legend Acetabular ShellOrtho Development Corporation2016-05-17290
K153216Alpine Cemented Hip SystemOrtho Development Corporation2016-02-181050
K152169Balanced Knee System TriMax CR Femoral Component and E-VitalOrtho Development Corporation2015-10-27840

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