Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho Kinematics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
153 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173247 | Surgical Planning Software version 1.1 | Ortho Kinematics, Inc. | 2017-11-08 | 33 | 0 |
| K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017-08-25 | 24 | 0 |
| K171617 | OKI Surgical Planning Software | Ortho Kinematics, Inc. | 2017-08-22 | 82 | 0 |
| K133875 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSI | Ortho Kinematics, Inc. | 2014-01-17 | 28 | 0 |
| K130743 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSI | Ortho Kinematics, Inc. | 2013-08-06 | 140 | 0 |
| K112109 | THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HA | Ortho Kinematics, Inc. | 2011-12-22 | 153 | 0 |
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