Medos International SARL: FDA clearances and approvals
Medos International SARL has 96 FDA 510(k) clearances (first 2010, latest 2026), across 24 product codes in 4 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 91 days, against 92 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Medos International SARL. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 80 |
| 2013 | 3 | 42 |
| 2014 | 3 | 116 |
| 2015 | 4 | 127 |
| 2016 | 11 | 94 |
| 2017 | 8 | 73 |
| 2018 | 10 | 113 |
| 2019 | 12 | 104 |
| 2020 | 7 | 127 |
| 2021 | 6 | 70 |
| 2022 | 8 | 111 |
| 2023 | 6 | 69 |
| 2024 | 2 | 70 |
| 2025 | 2 | 60 |
| 2026 | 2 | 108 |
Review time against the same product codes
Since 2017, Medos International SARL's cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 14 | 14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 11 | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 11 | 11 |
| OLO | Orthopedic Stereotaxic Instrument | 11 | 11 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 8 | 8 |
| NKG | Posterior Cervical Screw System | 6 | 6 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 5 | 5 |
| JXG | Shunt, Central Nervous System And Components | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| HRX | Arthroscope | 3 | 3 |
Plus 14 more product codes.
Review panels
- Orthopedic (76)
- Neurology (11)
- General and Plastic Surgery (7)
- Cardiovascular (2)
Most recent Medos International SARL 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | OLO | 2026-05-26 | 155 |
| K260240 | SYMPHONY Navigation Ready Instruments | OLO | 2026-03-27 | 60 |
| K253249 | TriALTIS Spine System | NKB | 2025-10-21 | 22 |
| K243249 | TriALTIS Spine System | NKB | 2025-01-17 | 98 |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | OLO | 2024-09-16 | 80 |
| K242042 | TriALTIS Spine System | NKB | 2024-09-09 | 59 |
| K233684 | TriALTIS Spine System | NKB | 2023-12-12 | 26 |
| K233366 | SYMPHONY OCT System | NKG | 2023-11-09 | 38 |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | MBI | 2023-10-06 | 50 |
| K231479 | TriALTIS Spine System | NKB | 2023-09-22 | 123 |
86 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2026-07-23.
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.
Device clinical trials
Medos International SARL is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05316311: A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis (Completed, started 2022-05-24)
- NCT04289480: Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms (Active not recruiting, started 2020-07-30)
Frequently asked questions
How many FDA 510(k) clearances does Medos International SARL have?
Medos International SARL has 96 FDA 510(k) clearances (first 2010, latest 2026), across 24 product codes in 4 review panels.
How long does FDA take to clear Medos International SARL's 510(k)s?
The median time from FDA receipt to decision across Medos International SARL's cleared 510(k)s is 90 days. Since 2017: 91 days, versus 92 days for all cleared 510(k)s in the same product codes.
What devices does Medos International SARL make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 14); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 11); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 11).
Has Medos International SARL had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Medos International SARL; the most recent began 2026-07-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 96 Medos International SARL clearances with predicates and recalls
- Run predicate analysis for product code NKB, Medos International SARL'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.