Medartis AG
BASEL Basel-Stadt, CH
MEDARTIS AG appears in FDA device records in BASEL Basel-Stadt, CH. FDA records list 67 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Medartis AG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Nextremity Solutions, LLC510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 67FDA records hold 67 510(k) clearances for Medartis AG between 1999 and 2026. The busiest year on record is 2020, with 8. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 3 |
| 2005 | 4 |
| 2007 | 1 |
| 2009 | 4 |
| 2010 | 1 |
| 2011 | 5 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 4 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 5 |
| 2020 | 8 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260761 | APTUS Clavicle System 2.8 | HRS | Substantially Equivalent | |
| K260934 | TITAN Nail; APTUS K-Wire System | HWC | Substantially Equivalent | |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | HRS | Substantially Equivalent | |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | HRS | Substantially Equivalent | |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | HRS | Substantially Equivalent | |
| K232105 | APTUS Foot System 2.8-3.5 | HRS | Substantially Equivalent | |
| K234062 | APTUS Hand Scaphoid Plates | HRS | Substantially Equivalent | |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | HWC | Substantially Equivalent | |
| K232324 | StealthFix Intraosseous Fixation System | JDR | Substantially Equivalent | |
| K232144 | Sterile Products of the APTUS System | HRS | Substantially Equivalent | |
| K230971 | APTUS® 3.5 TriLock Straight Plates | HRS | Substantially Equivalent | |
| K223853 | Medartis APTUS® Ulna Plates | HRS | Substantially Equivalent | |
| K221610 | Nextra CH Cannulated Hammertoe System | HWC | Substantially Equivalent | |
| K212979 | CalcShift™ Displacement Calcaneal Osteotomy System | HRS | Substantially Equivalent | |
| K220181 | StealthFix Intraosseous Fixation System | JDR | Substantially Equivalent | |
| K213301 | InCore Subtalar System | HWC | Substantially Equivalent | |
| K213530 | Nextra CH Cannulated Hammertoe System | HWC | Substantially Equivalent | |
| K212640 | Stratum® Ankle Fusion Plating System | HRS | Substantially Equivalent | |
| K211996 | Nexta PEEK Hammertoe Correction System | HWC | Substantially Equivalent | |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System | HWC | Substantially Equivalent | |
| K200785 | Stratum™ Reduced Size Foot Plating System | HRS | Substantially Equivalent | |
| K200840 | DuoHex CH Cannulated Hammertoe System | HWC | Substantially Equivalent | |
| K200124 | InCore MPJ System | HWC | Substantially Equivalent | |
| K193639 | APTUS® Foot 2.8-3.5 System | HRS | Substantially Equivalent | |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5 | HRS | Substantially Equivalent | |
| K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | HRS | Substantially Equivalent | |
| K192984 | APTUS Clavicle System | HRS | Substantially Equivalent | |
| K192578 | InCore TMT System | HWC | Substantially Equivalent | |
| K192297 | APTUS Wrist Arthrodesis Plates | HRS | Substantially Equivalent | |
| K191848 | APTUS Wrist Spanning Plates 2.5 | HRS | Substantially Equivalent | |
| K191636 | APTUS Foot System | JDR | Substantially Equivalent | |
| K190231 | InCore® Lapidus Sterile Kits | HWC | Substantially Equivalent | |
| K182201 | Stratum™ Foot Plating System | HRS | Substantially Equivalent | |
| K181009 | APTUS CMC-I Fusion Plate System | HRS | Substantially Equivalent | |
| K181425 | APTUS® Proximal Humerus System | HRS | Substantially Equivalent | |
| K180257 | InCore® Lapidus System | HWC | Substantially Equivalent | |
| K172170 | APTUS(R) Wrist 2.5 System | HRS | Substantially Equivalent | |
| K161861 | APTUS® Coronoid 2.0 | HRS | Substantially Equivalent | |
| K152548 | AXI+LINE Proximal Bunion Correction System | HRS | Substantially Equivalent | |
| K151160 | Arcus Staple System | JDR | Substantially Equivalent | |
| K142906 | APTUS Wrist 2.5 System | HRS | Substantially Equivalent | |
| K142581 | APTUS Foot System | HRS | Substantially Equivalent | |
| K141232 | APTUS ULNA SHORTENING 2.5 | HRS | Substantially Equivalent | |
| K140724 | MSP METATARSAL SHORTENING SYSTEM | HRS | Substantially Equivalent | |
| K133460 | APTUS CANNULATED COMPRESSION SCREWS | HWC | Substantially Equivalent | |
| K131061 | RESTORE BUNION CORRECTION SYSTEM | JDR | Substantially Equivalent | |
| K122031 | NEXTRA TI HAMMERTOE CORRECTION SYSTEM | HWC | Substantially Equivalent | |
| K120108 | APTUS PROXIMAL HUMERUS SYSTEM | HRS | Substantially Equivalent | |
| K112169 | APTUS WRIST ARTHRODESIS PLATES | HRS | Substantially Equivalent | |
| K112560 | APTUS(R) DISTAL HUMERUS SYSTEM | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003236702 | 3003236702 | MEDARTIS AG | HOCHBERGERSTRASSE 60E, BASEL Basel-Stadt CH-4057 CH | 2026 | and 8 more, listed in full below |
| 3009540749 | 3009540749 | Medartis Inc. | 1195 Polk Drive, Warsaw, IN 46582 US | 2026 | and 34 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- HWJAwl
- HXWBender
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- PLFBone Wedge
- EJFBracket, Metal, Orthodontic
- FZOChisel, Surgical, Manual
- HXDClamp
- GFCDriver, Surgical, Pin
- MQNExternal Mandibular Fixator And/Or Distractor
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- KIKHook, Bone
- HWAImpactor
- DZEImplant, Endosseous, Root-Form
- HXPInstrument, Bending Or Contouring
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- HWQPasser
- HTYPin, Fixation, Smooth
- JEYPlate, Bone
- HRSPlate, Fixation, Bone
- HXBProbe
- SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer
- HTHProtractor
- GACRasp, Surgical, General & Plastic Surgery
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- HWDStarter, Bone Screw
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GAHStylet, Surgical, General & Plastic Surgery
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2361-2026 | Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation | The cannulation of the CCS screw is not centered. | Class II | Open, Classified | |
| 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: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | Class II | Open, Classified | |
| 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: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| Z-0914-2022 | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | Class II | Terminated | |
| Z-0913-2022 | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | Class II | Terminated | |
| Z-0912-2022 | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | Class II | Terminated | |
| Z-0911-2022 | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | Class II | Terminated | |
| Z-0910-2022 | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | Class II | Terminated | |
| Z-0740-2022 | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision | Class II | Terminated | |
| Z-0739-2022 | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision | Class II | Terminated | |
| Z-1501-2021 | InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis. | Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended | Class II | Terminated | |
| Z-1500-2021 | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis. | Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended | Class II | Terminated | |
| Z-1458-2020 | Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes. | Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant | Class II | Terminated | |
| Z-1127-2020 | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation. | The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate. | Class II | Terminated | |
| Z-0778-2020 | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST | Components 2mm shorter than indicated on the package label | Class II | Terminated | |
| Z-0777-2020 | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST | Components 2mm shorter than indicated on the package label | Class II | Terminated | |
| Z-0776-2020 | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | Components 2mm shorter than indicated on the package label | Class II | Terminated | |
| Z-0534-2020 | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. | Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length | Class II | Terminated | |
| Z-0150-2015 | APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna. | A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain