Company · CH
Medartis AG
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (3 in 12 months)
5recalls (3 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2026 | K260761 | APTUS Clavicle System 2.8 Medartis AG, CH | HRS |
| Apr 17, 2026 | K260934 | TITAN Nail; APTUS K-Wire System Medartis AG, CH | HWC |
| Mar 16, 2026 | K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 Medartis AG, CH | HRS |
| Mar 7, 2025 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon Medartis AG, CH | HRS |
| Jun 20, 2024 | K240613 | APTUS Elbow Dorsal Olecranon Plates Medartis AG, CH | HRS |
| Apr 19, 2024 | K232105 | APTUS Foot System 2.8-3.5 Medartis AG, CH | HRS |
| Mar 21, 2024 | K234062 | APTUS Hand Scaphoid Plates Medartis AG, CH | HRS |
| Nov 3, 2023 | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension Medartis AG, CH | HWC |
| Aug 30, 2023 | K232324 | StealthFix Intraosseous Fixation System Medartis, Inc. | JDR |
| Aug 18, 2023 | K232144 | Sterile Products of the APTUS System Medartis AG, CH | HRS |
| Jun 2, 2023 | K230971 | APTUS® 3.5 TriLock Straight Plates Medartis AG, CH | HRS |
| Mar 30, 2023 | K223853 | Medartis APTUS® Ulna Plates Medartis AG, CH | HRS |
| Nov 6, 2020 | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System Medartis AG, CH | HWC |
| Mar 26, 2020 | K193639 | APTUS® Foot 2.8-3.5 System Medartis AG, CH | HRS |
| Mar 26, 2020 | K193633 | APTUS® Ankle Trauma System 2.8/3.5 Medartis AG, CH | HRS |
| Feb 16, 2020 | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System Medartis AG, CH | HRS |
| Jan 24, 2020 | K192984 | APTUS Clavicle System Medartis AG, CH | HRS |
| Nov 8, 2019 | K192297 | APTUS Wrist Arthrodesis Plates Medartis AG, CH | HRS |
| Sep 30, 2019 | K191848 | APTUS Wrist Spanning Plates 2.5 Medartis AG, CH | HRS |
| Aug 16, 2019 | K191636 | APTUS Foot System Medartis AG, CH | JDR |
| Aug 24, 2018 | K181009 | APTUS CMC-I Fusion Plate System Medartis AG, CH | HRS |
| Aug 5, 2018 | K181425 | APTUS® Proximal Humerus System Medartis AG, CH | HRS |
| Sep 8, 2017 | K172170 | APTUS(R) Wrist 2.5 System Medartis AG, CH | HRS |
| Feb 9, 2017 | K161861 | APTUS® Coronoid 2.0 Medartis AG, CH | HRS |
| Jun 9, 2015 | K142906 | APTUS Wrist 2.5 System Medartis AG, CH | HRS |
| Apr 9, 2015 | K142581 | APTUS Foot System Medartis AG, CH | HRS |
| Jun 23, 2014 | K141232 | APTUS ULNA SHORTENING 2.5 Medartis AG | HRS |
| Dec 18, 2013 | K133460 | APTUS CANNULATED COMPRESSION SCREWS Medartis AG | HWC |
| Apr 27, 2012 | K120108 | APTUS PROXIMAL HUMERUS SYSTEM Medartis AG | HRS |
| Jan 6, 2012 | K112169 | APTUS WRIST ARTHRODESIS PLATES Medartis AG | HRS |
| Dec 15, 2011 | K112560 | APTUS(R) DISTAL HUMERUS SYSTEM Medartis AG | HRS |
| Jun 28, 2011 | K110908 | APTUS FOOT 3.5 SYSTEM Medartis AG | HRS |
| Jun 2, 2011 | K110658 | APTUS CANNULATED COMPRESSION SCREWS Medartis AG | HWC |
| Jan 24, 2011 | K103332 | APTUS ULNA PLATES Medartis AG | HRS |
| Dec 10, 2010 | K102537 | APTUS 1.5 TRILOCK Medartis AG | HRS |
| Sep 23, 2009 | K092038 | APTUS K-WIRE SYSTEM Medartis AG | HTY |
| Jul 13, 2009 | K091479 | APTUS FOOT SYSTEM Medartis AG | HRS |
| Jul 1, 2009 | K090983 | APTUS 2.0/2.3 FOUR CORNER FUSION PLATE Medartis AG | HRS |
| Apr 23, 2009 | K090053 | APTUS 2.0 RADIAL HEAD SYSTEM Medartis AG | HRS |
| Sep 11, 2007 | K071612 | MODUS TRILOCK 2.0/2.3/2.5 Medartis AG | JEY |
| Oct 21, 2005 | K052061 | MODUS IMF SCREWS 2.0 Medartis, Inc. | DZE |
| Aug 23, 2005 | K051567 | APTUS TITANIUM OSTEOSYNTHESIS SYSTEM Medartis, Inc. | HRS |
| Aug 22, 2005 | K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM Medartis, Inc. | MQN |
| May 5, 2005 | K050934 | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM Medartis, Inc. | JEY |
| Nov 24, 1999 | K992683 | MODUS 2.5 MANDIBULAR TRAUMA SET Medartis AG | JEY |
| Nov 24, 1999 | K992682 | MODUS 2.5 MANDIBULAR RECONSTRUCTION SET Medartis AG | JEY |
| Sep 17, 1999 | K992106 | MODUS SYSTEM SELF-DRILLING SCREWS Medartis AG | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2026 | Medartis AG Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation Open, Classified |
HWC | K202589 |
| Mar 10, 2026 | Medartis AG Brand Name: APTUS
Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg
Model/Catalog Number: A-5850.16/1
Software Version: Not applicable.
Product Description: The APTUS fixation systems are used for frac Open, Classified |
HWC | K091479 |
| Mar 10, 2026 | Medartis AG Brand Name: APTUS
Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg
Model/Catalog Number: A-5750.16/1
Software Version: Not applicable.
Product Description: The APTUS fixation systems are used for frac Open, Classified |
HWC | K051567 |
| May 14, 2024 | Medartis Inc. APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system. Open, Classified |
HWC | K091479 |
| Oct 30, 2014 | Medartis, Inc. APTUS Ulna Shortening 2.5
Product Usage:
APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna. Terminated |
HWC | K141232 |