Novastep: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Novastep” (first 2015, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 263 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 |
|---|---|---|
| 2015 | 5 | 95 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 107 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 274 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Novastep took a median 263 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Novastep 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | JDR | 2023-12-04 | 263 |
| K223468 | Nexis® compressive screws | HWC | 2023-08-30 | 286 |
| K192356 | Airlock Centrolock Osteosynthesis Implant System | HRS | 2019-12-14 | 107 |
| K151277 | Airlock® osteosynthesis plate system | HRS | 2015-08-13 | 91 |
| K143523 | Airlock osteosynthesis plate system | HRS | 2015-04-06 | 115 |
| K143049 | LYNC intramedullary implant | HTY | 2015-02-19 | 119 |
| K143229 | Nexis osteosynthesis compressive screws | HWC | 2015-02-06 | 88 |
| K143146 | Nexis osteosynthesis snap-off screws | HWC | 2015-02-06 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Novastep.
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.
Device clinical trials
An industry sponsor named Novastep is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06888934: Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync (Recruiting, started 2024-11-04)
- NCT05361317: Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device (Active not recruiting, started 2022-06-13)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Novastep SAS (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Novastep?
FDA lists 8 510(k) clearances under the applicant name “Novastep” (first 2015, latest 2023), 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 Novastep?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novastep is 111 days. Since 2017: 263 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Novastep?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HWC (Screw, Fixation, Bone, 3); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 8 Novastep clearances with predicates and recalls
- Run predicate analysis for product code HRS, Novastep'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.