Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Additive Orthopaedics, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
442 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | 2022-06-28 | 442 | 0 |
| K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segme | Additive Orthopaedics, LLC | 2018-05-16 | 107 | 0 |
| K163593 | Additive Orthopaedics Bunion System | Additive Orthopaedics, LLC | 2017-06-20 | 181 | 0 |
| K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017-04-13 | 79 | 0 |
| K153207 | Additive Orthopaedics Bone Wedge System | Additive Orthopaedics, LLC | 2016-09-07 | 307 | 0 |
| K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016-06-01 | 120 | 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