Artfx Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Artfx Medical” (first 2022, latest 2024), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 184 days. Since 2017 the median was 184 days, against 90 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 |
|---|---|---|
| 2022 | 1 | 389 |
| 2023 | 1 | 643 |
| 2024 | 3 | 89 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Artfx Medical took a median 184 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Artfx Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242939 | ARTFX Trauma Bone Plate and Screw System | HRS | 2024-12-23 | 89 |
| K240889 | ARTFX Lumbar PEEK Cages | MAX | 2024-10-02 | 184 |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | ODP | 2024-06-28 | 88 |
| K212220 | ArtFX Spinal Fixation System | NKB | 2023-04-20 | 643 |
| K211718 | Venus Cervical Plate System | KWQ | 2022-06-28 | 389 |
Recalls
openFDA lists no recalls under a recalling firm named Artfx Medical.
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 Artfx Medical?
FDA lists 5 510(k) clearances under the applicant name “Artfx Medical” (first 2022, latest 2024), across 5 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 Artfx Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Artfx Medical is 184 days. Since 2017: 184 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Artfx Medical?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 1); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 5 Artfx Medical clearances with predicates and recalls
- Run predicate analysis for product code HRS, Artfx Medical'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.