Icotec AG: FDA clearances and approvals
Icotec AG has 16 FDA 510(k) clearances (first 2016, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time: 163 days. Since 2017 its median was 161 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Icotec AG.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 270 |
| 2017 | 0 | — |
| 2018 | 1 | 274 |
| 2019 | 1 | 108 |
| 2020 | 5 | 161 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 103 |
| 2024 | 4 | 206 |
| 2025 | 2 | 134 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Icotec AG's cleared 510(k)s took a median 161 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| PML | Bone Cement, Posterior Screw Augmentation | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Icotec AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | NKG | 2025-11-12 | 110 |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | NKB | 2025-02-27 | 157 |
| K233215 | icotec Anterior Cervical Plate System | KWQ | 2024-05-17 | 234 |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | MAX | 2024-04-05 | 207 |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | MQP | 2024-04-04 | 206 |
| K232628 | VADER® Pedicle System | NKB | 2024-02-26 | 181 |
| K230861 | VADER® Pedicle System Navigated Instruments | OLO | 2023-06-27 | 90 |
| K222789 | VADER® Pedicle System, G21 Cement | PML | 2023-01-09 | 116 |
| K201587 | icotec Anterior Cervical Plate System | KWQ | 2020-10-15 | 126 |
| K200596 | G21 Cement, VADER® Pedicle System | PML | 2020-10-13 | 221 |
6 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2023-11-28.
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 Icotec AG have?
Icotec AG has 16 FDA 510(k) clearances (first 2016, latest 2025), across 8 product codes in 1 review panel.
How long does FDA take to clear Icotec AG's 510(k)s?
The median time from FDA receipt to decision across Icotec AG's cleared 510(k)s is 163 days. Since 2017: 161 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Icotec AG make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 5); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MQP (Spinal Vertebral Body Replacement Device, 2).
Has Icotec AG had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Icotec AG; the most recent began 2023-11-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Icotec AG clearances with predicates and recalls
- Run predicate analysis for product code NKB, Icotec AG'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.