OSSIO , Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “OSSIO , Ltd.” (first 2019, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 126 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 253 |
| 2020 | 3 | 213 |
| 2021 | 2 | 41 |
| 2022 | 3 | 160 |
| 2023 | 3 | 180 |
| 2024 | 3 | 58 |
| 2025 | 3 | 50 |
| 2026 | 2 | 102 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name OSSIO , Ltd. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | 6 | 6 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 5 | 5 |
| MNU | Staple, Absorbable | 3 | 3 |
Review panels
- Orthopedic (20)
Most recent OSSIO , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | HWC | 2026-05-01 | 134 |
| K254055 | OSSIOfiber® Suture Anchor | MAI | 2026-02-24 | 69 |
| K252022 | OSSIOfiber® Interference Screw | MAI | 2025-08-19 | 50 |
| K251309 | OSSIOfiber® Suture Anchor | MAI | 2025-05-27 | 29 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | MAI | 2025-04-03 | 118 |
| K241932 | OSSIOfiber® Compression Staple | MNU | 2024-08-28 | 58 |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | HWC | 2024-07-03 | 58 |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | HWC | 2024-03-08 | 162 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | HTY | 2023-12-01 | 213 |
| K233302 | OSSIOfiber® Compression Staple | MNU | 2023-11-16 | 48 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named OSSIO , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under OSSIO , Ltd.?
FDA lists 20 510(k) clearances under the applicant name “OSSIO , Ltd.” (first 2019, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by OSSIO , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name OSSIO , Ltd. is 126 days. Since 2017: 126 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under OSSIO , Ltd.?
The most frequent FDA product codes under this applicant name are HTY (Pin, Fixation, Smooth, 6); HWC (Screw, Fixation, Bone, 6); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 5).
Next steps
- See all 20 OSSIO , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HTY, OSSIO , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.