# Medartis AG

- Location (FDA's records): Basel, CH
- FDA decisions: 47 (1999–2026): 47 510(k) clearances
- Names in FDA's records: Medartis AG (42); Medartis, Inc. (5)
- Product codes: HRS (32), HWC (6), JEY (4), JDR (2), MQN (1), DZE (1), HTY (1)
- 510(k) review time since 2016: median 89 days, against 96 for FDA's reviews in the same codes and years (14 of 24 faster)
- Predicates its devices cite: 158 (77 its own); citations of its devices by later devices: 138 (77 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 41 (https://510kreport.com/company/synthes-usa)
- Hand Innovations, Inc.: 4 (https://510kreport.com/company/hand-innovations)
- Elekta Instruments, Inc.: 4 (https://510kreport.com/company/elekta-instruments)
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Stryker Leibinger GmbH & Co KG: 3 (https://510kreport.com/company/stryker-leibinger)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- Acumed, LLC: 3 (https://510kreport.com/company/acumed)
- KLS-Martin L.P.: 2 (https://510kreport.com/company/kls-martin)

## Firms that cite its devices most
- Jeil Medical Corporation: 6 (https://510kreport.com/company/jeil-medical)
- Osteonic Co., Ltd.: 6 (https://510kreport.com/company/osteonic)
- Newclip Technics: 6 (https://510kreport.com/company/newclip-technics)
- Bonebridge AG: 4 (https://510kreport.com/company/bonebridge)
- Acumed, LLC: 4 (https://510kreport.com/company/acumed)
- GM Dos Reis Industria e Comercio Ltda.: 3 (https://510kreport.com/company/gm-dos-reis-industria-e-comercio)
- Biopro, Inc.: 3 (https://510kreport.com/company/biopro)
- Avanti Orthopaedics, Inc.: 2 (https://510kreport.com/company/avanti-orthopaedics)

## Its most-cited devices
- K051567: Aptus Titanium Osteosynthesis System (2005), cited by 22
- K142906: APTUS Wrist 2.5 System (2015), cited by 16
- K103332: Aptus Ulna Plates (2011), cited by 12
- K091479: Aptus Foot System (2009), cited by 9
- K092038: Aptus K-Wire System (2009), cited by 7
- K102537: Aptus 1.5 Trilock (2010), cited by 6

## Recent decisions
- K260761: APTUS Clavicle System 2.8 (Jun 5, 2026)
- K260934: TITAN Nail; APTUS K-Wire System (Apr 17, 2026)
- K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (Mar 16, 2026)
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon (Mar 7, 2025)
- K240613: APTUS Elbow Dorsal Olecranon Plates (Jun 20, 2024)
- K232105: APTUS Foot System 2.8-3.5 (Apr 19, 2024)
- K234062: APTUS Hand Scaphoid Plates (Mar 21, 2024)
- K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (Nov 3, 2023)

Source page: https://510kreport.com/company/medartis