S.M.A.I.O: FDA clearances and approvals
S.M.A.I.O has 13 FDA 510(k) clearances (first 2020, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 96 days. Since 2017 its median was 96 days, against 103 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 109 |
| 2021 | 1 | 96 |
| 2022 | 2 | 243 |
| 2023 | 2 | 94 |
| 2024 | 0 | — |
| 2025 | 2 | 24 |
| 2026 | 5 | 26 |
Review time against the same product codes
Since 2017, S.M.A.I.O's cleared 510(k)s took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 10 | 10 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
Review panels
- Orthopedic (10)
- Radiology (3)
Most recent S.M.A.I.O 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2026-09-04 | 25 |
| K261500 | KBA3D (v2.4.0) | LLZ | 2026-08-17 | 103 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2026-07-01 | 215 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2026-04-03 | 24 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2026-01-07 | 26 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2025-12-17 | 23 |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2025-07-08 | 26 |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | 2023-09-29 | 29 |
| K223841 | KBA3D | LLZ | 2023-05-30 | 159 |
| K211981 | KHEIRON® Spinal Fixation System | NKB | 2022-06-09 | 349 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named S.M.A.I.O.
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 S.M.A.I.O have?
S.M.A.I.O has 13 FDA 510(k) clearances (first 2020, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear S.M.A.I.O's 510(k)s?
The median time from FDA receipt to decision across S.M.A.I.O's cleared 510(k)s is 96 days. Since 2017: 96 days, versus 103 days for all cleared 510(k)s in the same product codes.
What devices does S.M.A.I.O make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 10); LLZ (System, Image Processing, Radiological, 3).
Has S.M.A.I.O had device recalls?
openFDA lists no recalls under a recalling firm name matching S.M.A.I.O. Related entities may recall under other names.
Next steps
- See all 13 S.M.A.I.O clearances with predicates and recalls
- Run predicate analysis for product code NKB, S.M.A.I.O'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.