Inion OY: FDA clearances and approvals
Inion OY has 14 FDA 510(k) clearances (first 2005, latest 2025), across 8 product codes in 3 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 74 days, against 105 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 110 |
| 2014 | 1 | 109 |
| 2015 | 1 | 139 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 30 |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 120 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Inion OY's cleared 510(k)s took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
| JEY | Plate, Bone | 2 | 2 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 2 |
| HBW | Fastener, Plate, Cranioplasty | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| OJB | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | 1 | 1 |
Review panels
- Orthopedic (10)
- Dental (3)
- Neurology (1)
Most recent Inion OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | JEY | 2025-11-07 | 182 |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | HBW | 2025-07-11 | 59 |
| K203105 | Inion CompressOn Screw | HWC | 2021-01-13 | 90 |
| K191764 | Inion BioRestore | MQV | 2019-07-31 | 30 |
| K151360 | Inion Spinal Graft Containment System | OJB | 2015-10-06 | 139 |
| K133932 | INION FREEDOMPIN | HTY | 2014-04-11 | 109 |
| K123672 | INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) | HWC | 2013-02-27 | 90 |
| K122890 | INION CPS ORBITAL PLATES | JEY | 2013-01-29 | 131 |
| K090177 | INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE | MQV | 2009-02-20 | 28 |
| K070998 | INION BIORESTORE | MQV | 2007-10-11 | 185 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Inion OY.
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.
Device clinical trials
Inion OY is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00300989: Inion OTPS Biodegradable Fixation System for the Ankle (Completed, started 2005-12)
Frequently asked questions
How many FDA 510(k) clearances does Inion OY have?
Inion OY has 14 FDA 510(k) clearances (first 2005, latest 2025), across 8 product codes in 3 review panels.
How long does FDA take to clear Inion OY's 510(k)s?
The median time from FDA receipt to decision across Inion OY's cleared 510(k)s is 90 days. Since 2017: 74 days, versus 105 days for all cleared 510(k)s in the same product codes.
What devices does Inion OY make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 3); MQV (Filler, Bone Void, Calcium Compound, 3); JEY (Plate, Bone, 2).
Has Inion OY had device recalls?
openFDA lists no recalls under a recalling firm name matching Inion OY. Related entities may recall under other names.
Next steps
- See all 14 Inion OY clearances with predicates and recalls
- Run predicate analysis for product code HWC, Inion OY'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.