Joimax GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Joimax GmbH” (first 2005, latest 2021), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 83 days. Since 2017 the median was 196 days, against 94 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 71 |
| 2016 | 1 | 168 |
| 2017 | 1 | 74 |
| 2018 | 0 | — |
| 2019 | 1 | 83 |
| 2020 | 1 | 309 |
| 2021 | 1 | 335 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Joimax GmbH took a median 196 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
Most recent Joimax GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | MAX | 2021-09-01 | 335 |
| K192663 | Joimax Intracs System | OLO | 2020-07-30 | 309 |
| K192680 | Percusys® Plus Pedicle Screw System | NKB | 2019-12-18 | 83 |
| K170358 | joimax Endovapor 2 | GEI | 2017-04-21 | 74 |
| K161378 | joimax Electrosurgical Instruments | GEI | 2016-11-02 | 168 |
| K151143 | EndoLIF On-Cage | MAX | 2015-07-09 | 71 |
| K051827 | JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE | HRX | 2005-08-12 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Joimax GmbH.
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 Joimax GmbH?
FDA lists 7 510(k) clearances under the applicant name “Joimax GmbH” (first 2005, latest 2021), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Joimax GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Joimax GmbH is 83 days. Since 2017: 196 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Joimax GmbH?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); HRX (Arthroscope, 1).
Next steps
- See all 7 Joimax GmbH clearances with predicates and recalls
- Run predicate analysis for product code GEI, Joimax GmbH'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.