Neosteo: FDA clearances and approvals
Neosteo has 6 FDA 510(k) clearances (first 2013, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time: 94 days. Since 2017 its median was 175 days, against 96 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Neosteo.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 98 |
| 2014 | 0 | — |
| 2015 | 2 | 34 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 91 |
| 2020 | 1 | 175 |
| 2021 | 0 | — |
| 2022 | 1 | 183 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Neosteo's cleared 510(k)s took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 4 | 4 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Neosteo 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212545 | FlexitSystem Knee osteotomy system | HRS | 2022-02-11 | 183 |
| K192447 | Superelastic Staple | JDR | 2020-02-28 | 175 |
| K191424 | Interphalangeal Joint Fusion Device Range | HWC | 2019-08-28 | 91 |
| K153182 | SELF- COMPRESSIVE SCREW | HWC | 2015-11-25 | 22 |
| K150772 | Snap-Off Self-Compressive Screw | HWC | 2015-05-08 | 45 |
| K131471 | SELF-COMPRESSIVE SCREW | HWC | 2013-08-28 | 98 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-11-03.
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 Neosteo have?
Neosteo has 6 FDA 510(k) clearances (first 2013, latest 2022), across 3 product codes in 1 review panel.
How long does FDA take to clear Neosteo's 510(k)s?
The median time from FDA receipt to decision across Neosteo's cleared 510(k)s is 94 days. Since 2017: 175 days, versus 96 days for all cleared 510(k)s in the same product codes.
What devices does Neosteo make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 4); HRS (Plate, Fixation, Bone, 1); JDR (Staple, Fixation, Bone, 1).
Has Neosteo had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Neosteo; the most recent began 2020-11-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Neosteo clearances with predicates and recalls
- Run predicate analysis for product code HWC, Neosteo'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.