Data / Medical devices / United States / Medartis Inc.
Medartis Inc.: FDA-registered device maker in Warsaw, IN, United States, 39 510(k) clearances and 1 PMA approval
Medartis Inc. is registered with the FDA (registration 3009540749) in Warsaw, IN, United States. It lists 45 device types. The FDA files 39 510(k) clearances and 1 PMA approval under its listings, the newest dated June 5, 2026. 8 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009540749
- Address
- 1195 Polk Drive, Warsaw, IN, United States, 46582
- Owner or operator
- MEDARTIS AG (9033581)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 15, 1998
- Registered through
- 2027
- Brand names listed
- APTUS 1.5 TriLock, APTUS 2 Radial Head System, APTUS 2/2.3 Four Corner Fusion Plate, APTUS Ankle Trauma System 2.8/3.5, APTUS CMC-I Fusion Plate System, APTUS Cannulated Compression Screws, APTUS Cannulated Compression Screws 5/7, APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2026 | K260761 | APTUS Clavicle System 2.8 | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| March 16, 2026 | K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| March 7, 2025 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| June 20, 2024 | K240613 | APTUS Elbow Dorsal Olecranon Plates | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| August 30, 2023 | K232324 | StealthFix Intraosseous Fixation System | JDR | Substantially Equivalent | Medartis, Inc. | accessdata.fda.gov |
| May 20, 2022 | K212979 | CalcShift Displacement Calcaneal Osteotomy System | HRS | Substantially Equivalent | Nextremity Solutions, Inc. | accessdata.fda.gov |
| March 22, 2022 | K220181 | StealthFix Intraosseous Fixation System | JDR | Substantially Equivalent | Nextremity Solutions, Inc. | accessdata.fda.gov |
| November 6, 2020 | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System | HWC | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| March 26, 2020 | K193639 | APTUS® Foot 2.8-3.5 System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| March 26, 2020 | K193633 | APTUS® Ankle Trauma System 2.8/3.5 | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| March 23, 2020 | K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range | HRS | Substantially Equivalent | Field Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| February 16, 2020 | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| January 24, 2020 | K192984 | APTUS Clavicle System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| January 7, 2020 | K192754 | Avenger Radial Head System | KWI | Substantially Equivalent | In2bones USA, LLC | accessdata.fda.gov |
| November 8, 2019 | K192297 | APTUS Wrist Arthrodesis Plates | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| August 16, 2019 | K191636 | APTUS Foot System | JDR | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| August 24, 2018 | K181009 | APTUS CMC-I Fusion Plate System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| August 5, 2018 | K181425 | APTUS® Proximal Humerus System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| July 17, 2018 | K180348 | Field Orthopaedics Micro Screw System | HWC | Substantially Equivalent | Field Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| September 8, 2017 | K172170 | APTUS(R) Wrist 2.5 System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| February 9, 2017 | K161861 | APTUS® Coronoid 2.0 | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| February 1, 2017 | K163440 | Stealth Staple System | JDR | Substantially Equivalent | First Ray, LLC | accessdata.fda.gov |
| April 8, 2016 | K153622 | First Ray Internal Bone Staple System | JDR | Substantially Equivalent | First Ray, LLC | accessdata.fda.gov |
| June 9, 2015 | K142906 | APTUS Wrist 2.5 System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| April 9, 2015 | K142581 | APTUS Foot System | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| June 23, 2014 | K141232 | APTUS ULNA SHORTENING 2.5 | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| December 18, 2013 | K133460 | APTUS CANNULATED COMPRESSION SCREWS | HWC | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| April 27, 2012 | K120108 | APTUS PROXIMAL HUMERUS SYSTEM | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| January 6, 2012 | K112169 | APTUS WRIST ARTHRODESIS PLATES | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| December 15, 2011 | K112560 | APTUS(R) DISTAL HUMERUS SYSTEM | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| June 28, 2011 | K110908 | APTUS FOOT 3.5 SYSTEM | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| June 2, 2011 | K110658 | APTUS CANNULATED COMPRESSION SCREWS | HWC | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| January 24, 2011 | K103332 | APTUS ULNA PLATES | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| December 10, 2010 | K102537 | APTUS 1.5 TRILOCK | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| September 23, 2009 | K092038 | APTUS K-WIRE SYSTEM | HTY | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| July 13, 2009 | K091479 | APTUS FOOT SYSTEM | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| July 1, 2009 | K090983 | APTUS 2.0/2.3 FOUR CORNER FUSION PLATE | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| April 23, 2009 | K090053 | APTUS 2.0 RADIAL HEAD SYSTEM | HRS | Substantially Equivalent | Medartis AG | accessdata.fda.gov |
| August 23, 2005 | K051567 | APTUS TITANIUM OSTEOSYNTHESIS SYSTEM | HRS | Substantially Equivalent | Medartis, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 10, 2025 | P240020 | TOUCH® CMC 1 Prosthesis | SFA | 6 | June 24, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 12, 2024 | 94445 | Class II | Ongoing | 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. | accessdata.fda.gov |
| February 10, 2022 | 89764 | Class II | Terminated | 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 | accessdata.fda.gov |
| January 13, 2022 | 89588 | Class II | Terminated | 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 | accessdata.fda.gov |
| March 26, 2021 | 87665 | Class II | Terminated | 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 | accessdata.fda.gov |
| February 12, 2020 | 84924 | Class II | Terminated | 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 fo | 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 | accessdata.fda.gov |
| December 16, 2019 | 84694 | Class II | Terminated | 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. | accessdata.fda.gov |
| November 11, 2019 | 84405 | Class II | Terminated | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | Components 2mm shorter than indicated on the package label | accessdata.fda.gov |
| October 9, 2019 | 84160 | Class II | Terminated | 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, osteotomi | Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length | accessdata.fda.gov |
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Updated June 24, 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.