Astura Medical: FDA clearances and approvals
Astura Medical has 29 FDA 510(k) clearances (first 2016, latest 2026), across 14 product codes in 1 review panel. Median 510(k) review time: 148 days. Since 2017 its median was 149 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 4 | 140 |
| 2017 | 2 | 150 |
| 2018 | 5 | 130 |
| 2019 | 3 | 200 |
| 2020 | 3 | 223 |
| 2021 | 1 | 128 |
| 2022 | 1 | 93 |
| 2023 | 5 | 160 |
| 2024 | 2 | 216 |
| 2025 | 2 | 84 |
| 2026 | 1 | 134 |
Review time against the same product codes
Since 2017, Astura Medical's cleared 510(k)s took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (29)
Most recent Astura Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | PML | 2026-01-22 | 134 |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | NKB | 2025-10-21 | 85 |
| K243259 | MASADA Modular Spinal Fixation System | NKB | 2025-01-07 | 84 |
| K240160 | EGPS Navigated Instruments | OLO | 2024-10-17 | 272 |
| K233359 | DOMINION Expandable Corpectomy System | MQP | 2024-03-08 | 161 |
| K231694 | MASADA Modular Spinal Fixation System | NKB | 2023-11-16 | 160 |
| K232211 | REUNION Sacroiliac Joint Fusion System | OUR | 2023-10-24 | 90 |
| K223335 | SIRION Lateral Lumbar Interbody System | MAX | 2023-05-09 | 189 |
| K222097 | OLYMPIC Deformity Band System | OWI | 2023-05-04 | 290 |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | OVD | 2023-01-19 | 149 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Astura Medical.
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 Astura Medical have?
Astura Medical has 29 FDA 510(k) clearances (first 2016, latest 2026), across 14 product codes in 1 review panel.
How long does FDA take to clear Astura Medical's 510(k)s?
The median time from FDA receipt to decision across Astura Medical's cleared 510(k)s is 148 days. Since 2017: 149 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Astura Medical make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7); NKB (Thoracolumbosacral Pedicle Screw System, 5); OLO (Orthopedic Stereotaxic Instrument, 3).
Has Astura Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Astura Medical. Related entities may recall under other names.
Next steps
- See all 29 Astura Medical clearances with predicates and recalls
- Run predicate analysis for product code MAX, Astura Medical'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.