Medartis AG
FDA Regulatory Profile
Medartis AG appears in FDA public data with 5 recalls, 47 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2361-2026, Class II) was initiated on April 24, 2026. Its most recent 510(k) clearance was granted on June 5, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 47
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2361-2026 | Class II | Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Sc | April 24, 2026 |
| Z-1550-2026 | Class II | Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16 | January 9, 2026 |
| Z-1549-2026 | Class II | Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16 | January 9, 2026 |
| Z-1821-2024 | Class II | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation | April 12, 2024 |
| Z-0150-2015 | Class II | APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fra | October 1, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260761 | APTUS Clavicle System 2.8 | June 5, 2026 |
| K260934 | TITAN Nail; APTUS K-Wire System | April 17, 2026 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | March 16, 2026 |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | March 7, 2025 |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | June 20, 2024 |
| K232105 | APTUS Foot System 2.8-3.5 | April 19, 2024 |
| K234062 | APTUS Hand Scaphoid Plates | March 21, 2024 |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | November 3, 2023 |
| K232324 | StealthFix Intraosseous Fixation System | August 30, 2023 |
| K232144 | Sterile Products of the APTUS System | August 18, 2023 |
| K230971 | APTUS® 3.5 TriLock Straight Plates | June 2, 2023 |
| K223853 | Medartis APTUS® Ulna Plates | March 30, 2023 |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System | November 6, 2020 |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5 | March 26, 2020 |
| K193639 | APTUS® Foot 2.8-3.5 System | March 26, 2020 |
| K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | February 16, 2020 |
| K192984 | APTUS Clavicle System | January 24, 2020 |
| K192297 | APTUS Wrist Arthrodesis Plates | November 8, 2019 |
| K191848 | APTUS Wrist Spanning Plates 2.5 | September 30, 2019 |
| K191636 | APTUS Foot System | August 16, 2019 |