Medartis AG: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Medartis AG” (first 1999, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 102 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 | 2 | 134 |
| 2013 | 1 | 36 |
| 2014 | 1 | 41 |
| 2015 | 2 | 226 |
| 2016 | 0 | — |
| 2017 | 2 | 135 |
| 2018 | 2 | 98 |
| 2019 | 3 | 77 |
| 2020 | 5 | 90 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 4 | 78 |
| 2024 | 3 | 107 |
| 2025 | 1 | 105 |
| 2026 | 3 | 88 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medartis AG took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 31 | 31 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| JEY | Plate, Bone | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (39)
- Dental (3)
Most recent Medartis AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260761 | APTUS Clavicle System 2.8 | HRS | 2026-06-05 | 88 |
| K260934 | TITAN Nail; APTUS K-Wire System | HWC | 2026-04-17 | 28 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | HRS | 2026-03-16 | 98 |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | HRS | 2025-03-07 | 105 |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | HRS | 2024-06-20 | 107 |
| K232105 | APTUS Foot System 2.8-3.5 | HRS | 2024-04-19 | 280 |
| K234062 | APTUS Hand Scaphoid Plates | HRS | 2024-03-21 | 90 |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | HWC | 2023-11-03 | 98 |
| K232144 | Sterile Products of the APTUS System | HRS | 2023-08-18 | 30 |
| K230971 | APTUS® 3.5 TriLock Straight Plates | HRS | 2023-06-02 | 58 |
32 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2026-04-24.
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 Medartis AG is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03640793: Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS) (Completed, started 2017-10-09)
- NCT02094482: Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS) (Completed, started 2014-04)
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.
- Medartis, Inc. (5 510(k)s)
- Medartis Medizinprodukte Und Forschung AG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medartis AG?
FDA lists 42 510(k) clearances under the applicant name “Medartis AG” (first 1999, latest 2026), 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 Medartis AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medartis AG is 90 days. Since 2017: 90 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medartis AG?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 31); HWC (Screw, Fixation, Bone, 6); JEY (Plate, Bone, 3).
Next steps
- See all 42 Medartis AG clearances with predicates and recalls
- Run predicate analysis for product code HRS, Medartis AG'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.