Medartis AG
Medical device manufacturer in Basel, CH.
47510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260761 | APTUS Clavicle System 2.8HRS · Traditional | 06/05/2026SE |
| K260934 | TITAN Nail; APTUS K-Wire SystemHWC · Special | 04/17/2026SE |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS · Traditional | 03/16/2026SE |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS · Traditional | 03/07/2025SE |
| K240613 | APTUS Elbow Dorsal Olecranon PlatesHRS · Traditional | 06/20/2024SE |
| K232105 | APTUS Foot System 2.8-3.5HRS · Traditional | 04/19/2024SE |
| K234062 | APTUS Hand Scaphoid PlatesHRS · Traditional | 03/21/2024SE |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC · Traditional | 11/03/2023SE |
| K232324 | StealthFix Intraosseous Fixation SystemJDR · Special | 08/30/2023SE |
| K232144 | Sterile Products of the APTUS SystemHRS · Special | 08/18/2023SE |
| K230971 | APTUS® 3.5 TriLock Straight PlatesHRS · Traditional | 06/02/2023SE |
| K223853 | Medartis APTUS® Ulna PlatesHRS · Traditional | 03/30/2023SE |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…HWC · Traditional | 11/06/2020SE |
| K193639 | APTUS® Foot 2.8-3.5 SystemHRS · Traditional | 03/26/2020SE |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5HRS · Traditional | 03/26/2020SE |
| K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS · Traditional | 02/16/2020SE |
| K192984 | APTUS Clavicle SystemHRS · Traditional | 01/24/2020SE |
| K192297 | APTUS Wrist Arthrodesis PlatesHRS · Traditional | 11/08/2019SE |
| K191848 | APTUS Wrist Spanning Plates 2.5HRS · Traditional | 09/30/2019SE |
| K191636 | APTUS Foot SystemJDR · Traditional | 08/16/2019SE |
| K181009 | APTUS CMC-I Fusion Plate SystemHRS · Traditional | 08/24/2018SE |
| K181425 | APTUS® Proximal Humerus SystemHRS · Traditional | 08/05/2018SE |
| K172170 | APTUS(R) Wrist 2.5 SystemHRS · Traditional | 09/08/2017SE |
| K161861 | APTUS® Coronoid 2.0HRS · Traditional | 02/09/2017SE |
| K142906 | APTUS Wrist 2.5 SystemHRS · Traditional | 06/09/2015SE |
| K142581 | APTUS Foot SystemHRS · Traditional | 04/09/2015SE |
| K141232 | Aptus Ulna Shortening 2.5HRS · Traditional | 06/23/2014SE |
| K133460 | Aptus Cannulated Compression ScrewsHWC · Traditional | 12/18/2013SE |
| K120108 | Aptus Proximal Humerus SystemHRS · Traditional | 04/27/2012SE |
| K112169 | Aptus Wrist Arthrodesis PlatesHRS · Traditional | 01/06/2012SE |
| K112560 | Aptus(R) Distal Humerus SystemHRS · Traditional | 12/15/2011SE |
| K110908 | Aptus Foot 3.5 SystemHRS · Traditional | 06/28/2011SE |
| K110658 | Aptus Cannulated Compression ScrewsHWC · Traditional | 06/02/2011SE |
| K103332 | Aptus Ulna PlatesHRS · Traditional | 01/24/2011SE |
| K102537 | Aptus 1.5 TrilockHRS · Special | 12/10/2010SE |
| K092038 | Aptus K-Wire SystemHTY · Traditional | 09/23/2009SE |
| K091479 | Aptus Foot SystemHRS · Traditional | 07/13/2009SE |
| K090983 | Aptus 2.0/2.3 Four Corner Fusion PlateHRS · Traditional | 07/01/2009SE |
| K090053 | Aptus 2.0 Radial Head SystemHRS · Traditional | 04/23/2009SE |
| K071612 | Modus Trilock 2.0/2.3/2.5JEY · Traditional | 09/11/2007SE |
| K052061 | Modus Imf Screws 2.0DZE · Traditional | 10/21/2005SE |
| K051567 | Aptus Titanium Osteosynthesis SystemHRS · Traditional | 08/23/2005SE |
| K051946 | Modus Modular Distraction Osteogenesis SystemMQN · Traditional | 08/22/2005SE |
| K050934 | Modus Titanium Osteosynthesis SystemJEY · Special | 05/05/2005SE |
| K992683 | Modus 2.5 Mandibular Trauma SetJEY · Traditional | 11/24/1999SE |
| K992682 | Modus 2.5 Mandibular Reconstruction SetJEY · Traditional | 11/24/1999SE |
| K992106 | Modus System Self-Drilling ScrewsHWC · Traditional | 09/17/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2361-2026 Class II | Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated…The cannulation of the CCS screw is not centered. | 04/24/2026Open, Classified |
| Z-1550-2026 Class II | Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number:…Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | 01/09/2026Open, Classified |
| Z-1549-2026 Class II | Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number:…Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | 01/09/2026Open, Classified |
| Z-1821-2024 Class II | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the…Screw is 16mm long instead of 22mm long. | 04/12/2024Open, Classified |
| Z-0150-2015 Class II | APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated…A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage… | 10/01/2014Terminated |