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Data / Medical devices / Switzerland / Medartis AG

Medartis AG: FDA-registered device maker in BASEL Basel-Stadt, Switzerland, 46 510(k) clearances

Medartis AG is registered with the FDA (registration 3003236702) in BASEL Basel-Stadt, Switzerland. It lists 19 device types. The FDA files 46 510(k) clearances under its listings, the newest dated June 5, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Medartis AG
FDA registration number
3003236702
Address
Hochbergerstrasse 60e, BASEL Basel-Stadt, Switzerland, CH-4057
Owner or operator
MEDARTIS AG (9033581)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
April 15, 1998
Registered through
2027
Brand names listed
APTUS 1.5 TriLock, APTUS 2 Radial Head System, APTUS 2.5 TriLock Distal Ulna Plates, APTUS 2/2.3 Four Corner Fusion Plate, APTUS 3.5 Straight Plates, APTUS Ankle Trauma System 2.8/3.5, APTUS CMC-I Fusion Plate System, APTUS Cannulated Compression Screws and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Bone WedgePLF2Manufactureraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Manufactureraccessdata.fda.gov
External Mandibular Fixator And/Or DistractorMQN2Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufactureraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, PolymerKWI2Complaint file establishment, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 5, 2026K260761APTUS Clavicle System 2.8HRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
April 17, 2026K260934TITAN Nail; APTUS K-Wire SystemHWCSubstantially EquivalentMedartis AGaccessdata.fda.gov
March 16, 2026K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
March 7, 2025K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
June 20, 2024K240613APTUS Elbow Dorsal Olecranon PlatesHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
April 19, 2024K232105APTUS Foot System 2.8-3.5HRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
March 21, 2024K234062APTUS Hand Scaphoid PlatesHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
November 3, 2023K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWCSubstantially EquivalentMedartis AGaccessdata.fda.gov
August 18, 2023K232144Sterile Products of the APTUS SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
June 2, 2023K230971APTUS® 3.5 TriLock Straight PlatesHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
March 30, 2023K223853Medartis APTUS® Ulna PlatesHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
November 6, 2020K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemHWCSubstantially EquivalentMedartis AGaccessdata.fda.gov
March 26, 2020K193639APTUS® Foot 2.8-3.5 SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
March 26, 2020K193633APTUS® Ankle Trauma System 2.8/3.5HRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
February 16, 2020K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
January 24, 2020K192984APTUS Clavicle SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
January 7, 2020K192754Avenger Radial Head SystemKWISubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
November 8, 2019K192297APTUS Wrist Arthrodesis PlatesHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
August 16, 2019K191636APTUS Foot SystemJDRSubstantially EquivalentMedartis AGaccessdata.fda.gov
August 24, 2018K181009APTUS CMC-I Fusion Plate SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
August 5, 2018K181425APTUS® Proximal Humerus SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
September 8, 2017K172170APTUS(R) Wrist 2.5 SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
February 9, 2017K161861APTUS® Coronoid 2.0HRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
June 9, 2015K142906APTUS Wrist 2.5 SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
April 9, 2015K142581APTUS Foot SystemHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
June 23, 2014K141232APTUS ULNA SHORTENING 2.5HRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
December 18, 2013K133460APTUS CANNULATED COMPRESSION SCREWSHWCSubstantially EquivalentMedartis AGaccessdata.fda.gov
April 27, 2012K120108APTUS PROXIMAL HUMERUS SYSTEMHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
January 6, 2012K112169APTUS WRIST ARTHRODESIS PLATESHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
December 15, 2011K112560APTUS(R) DISTAL HUMERUS SYSTEMHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
June 28, 2011K110908APTUS FOOT 3.5 SYSTEMHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
June 2, 2011K110658APTUS CANNULATED COMPRESSION SCREWSHWCSubstantially EquivalentMedartis AGaccessdata.fda.gov
January 24, 2011K103332APTUS ULNA PLATESHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
December 10, 2010K102537APTUS 1.5 TRILOCKHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
September 23, 2009K092038APTUS K-WIRE SYSTEMHTYSubstantially EquivalentMedartis AGaccessdata.fda.gov
July 13, 2009K091479APTUS FOOT SYSTEMHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
July 1, 2009K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
April 23, 2009K090053APTUS 2.0 RADIAL HEAD SYSTEMHRSSubstantially EquivalentMedartis AGaccessdata.fda.gov
September 11, 2007K071612MODUS TRILOCK 2.0/2.3/2.5JEYSubstantially EquivalentMedartis AGaccessdata.fda.gov
October 21, 2005K052061MODUS IMF SCREWS 2.0DZESubstantially EquivalentMedartis, Inc.accessdata.fda.gov
August 23, 2005K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMHRSSubstantially EquivalentMedartis, Inc.accessdata.fda.gov
August 22, 2005K051946MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEMMQNSubstantially EquivalentMedartis, Inc.accessdata.fda.gov
May 5, 2005K050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEMJEYSubstantially EquivalentMedartis, Inc.accessdata.fda.gov
December 29, 1999K993862MODUS SAGITTAL SPLIT PLATEJEYSubstantially EquivalentThe Straumann Co.accessdata.fda.gov
November 24, 1999K992682MODUS 2.5 MANDIBULAR RECONSTRUCTION SETJEYSubstantially EquivalentMedartis AGaccessdata.fda.gov
September 17, 1999K992106MODUS SYSTEM SELF-DRILLING SCREWSHWCSubstantially EquivalentMedartis AGaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 24, 202698952Class IIOngoingMedartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixationThe cannulation of the CCS screw is not centered.accessdata.fda.gov
January 9, 202698353Class IIOngoingBrand 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 fractures, osteotomies aMix up between specified lots of 2.5mm and 2.8mm outer diameter screws.accessdata.fda.gov

Compare with other makers

Updated June 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.