Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avitus Orthopaedics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
123 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | Avitus Orthopaedics, Inc. | 2023-07-17 | 59 | 0 |
| K230492 | Avitus® Precision Autograft Delivery System | Avitus Orthopaedics, Inc. | 2023-06-26 | 123 | 0 |
| K210631 | Avitus(r) Bone Harvester | Avitus Orthopaedics, Inc. | 2021-03-31 | 28 | 0 |
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone | Avitus Orthopaedics, Inc. | 2017-03-20 | 25 | 0 |
| K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015-10-23 | 53 | 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