Chrysalis Intelligence · Sponsors · Medartis AG

Medartis AG

Basel, CH · 17 510(k) clearances · 3 recalls

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Total clearances
17
2020-01-24 → 2026-06-05
Last 12 months
3
Product codes
3
Most recent
2026-06-05
Name variants in FDA filings: Medartis AG / Medartis, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 13 2026-06-05
HWC Screw, Fixation, Bone Class II Orthopedic 3 2026-04-17
JDR Staple, Fixation, Bone Class II Orthopedic 1 2023-08-30
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2026-01-09
DateSeverityStatusRecall # ProductCodeReason
2026-01-09 Class II Ongoing Z-1550-2026 Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version… — Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
2026-01-09 Class II Ongoing Z-1549-2026 Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version… — Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
2024-04-12 Class II Ongoing Z-1821-2024 APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system. — Screw is 16mm long instead of 22mm long.
Filings

All 510(k) clearances (17)

Date K-number Device Code Class Specialty
2026-06-05 K260761 APTUS Clavicle System 2.8 HRS Class II Orthopedic
2026-04-17 K260934 TITAN Nail; APTUS K-Wire System HWC Class II Orthopedic
2026-03-16 K253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5 HRS Class II Orthopedic
2025-03-07 K243610 APTUS Hand System; APTUS Elbow Dorsal Olecranon HRS Class II Orthopedic
2024-06-20 K240613 APTUS Elbow Dorsal Olecranon Plates HRS Class II Orthopedic
2024-04-19 K232105 APTUS Foot System 2.8-3.5 HRS Class II Orthopedic
2024-03-21 K234062 APTUS Hand Scaphoid Plates HRS Class II Orthopedic
2023-11-03 K232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension HWC Class II Orthopedic
2023-08-30 K232324 StealthFix Intraosseous Fixation System JDR Class II Orthopedic
2023-08-18 K232144 Sterile Products of the APTUS System HRS Class II Orthopedic
2023-06-02 K230971 APTUS® 3.5 TriLock Straight Plates HRS Class II Orthopedic
2023-03-30 K223853 Medartis APTUS® Ulna Plates HRS Class II Orthopedic
2020-11-06 K202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System HWC Class II Orthopedic
2020-03-26 K193639 APTUS® Foot 2.8-3.5 System HRS Class II Orthopedic
2020-03-26 K193633 APTUS® Ankle Trauma System 2.8/3.5 HRS Class II Orthopedic
2020-02-16 K193554 APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System HRS Class II Orthopedic
2020-01-24 K192984 APTUS Clavicle System HRS Class II Orthopedic
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence