Avitus Orthopaedics, Inc.: FDA clearances and approvals
Avitus Orthopaedics, Inc. has 5 FDA 510(k) clearances (first 2015, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time: 53 days. Since 2017 its median was 44 days, against 154 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Avitus Orthopaedics, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 53 |
| 2016 | 0 | — |
| 2017 | 1 | 25 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 2 | 91 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Avitus Orthopaedics, Inc.'s cleared 510(k)s took a median 44 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
Review panels
Most recent Avitus Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | FMF | 2023-07-17 | 59 |
| K230492 | Avitus® Precision Autograft Delivery System | FMF | 2023-06-26 | 123 |
| K210631 | Avitus(r) Bone Harvester | KNW | 2021-03-31 | 28 |
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm | KNW | 2017-03-20 | 25 |
| K152474 | Avitus Bone Harvester | KNW | 2015-10-23 | 53 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-02-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Avitus Orthopaedics, Inc. have?
Avitus Orthopaedics, Inc. has 5 FDA 510(k) clearances (first 2015, latest 2023), across 2 product codes in 2 review panels.
How long does FDA take to clear Avitus Orthopaedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Avitus Orthopaedics, Inc.'s cleared 510(k)s is 53 days. Since 2017: 44 days, versus 154 days for all cleared 510(k)s in the same product codes.
What devices does Avitus Orthopaedics, Inc. make?
Its most frequent FDA product codes are KNW (Instrument, Biopsy, 3); FMF (Syringe, Piston, 2).
Has Avitus Orthopaedics, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Avitus Orthopaedics, Inc; the most recent began 2019-02-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Avitus Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Avitus Orthopaedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.