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US
Last updated September 17, 2026
What Medartis Inc. makes
Medartis Inc. manufactures orthopaedic hardware including non-bioabsorbable bone screws, fixation plates, and internal fixation system kits. Their reusable devices include sterilization/disinfection containers, surgical implant templates, and positioning instruments for orthopaedic prosthesis implantation. The APTUS and Stratum Ankle systems are among the products designed for bone stabilization and joint replacement procedures.
The company’s portfolio is regulated under FDA’s UDI system, with devices classified as Class I and Class II. Products are listed in the FDA’s Unique Device Identifier database. Medartis Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1195 Polk Drive, Warsaw, IN, 46582
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009540749
- DUNS Number
- 192756786
Catalogue (5070)
Page 102 of 102| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stratum Ankle | SAANTSMRTW | FDA UDI | Class II | Active |
| Stratum | STRM-LK-3546ST | FDA UDI | Class II | Unknown |
| InCore Subtalar | ICSUB55094 | FDA UDI | Class II | Active |
| InCore Lapidus | IJ-LAP-5928RP | FDA UDI | Class II | Active |
| Stratum Ankle | SALS3558NS | FDA UDI | Class II | Active |
| Stratum Ankle | SAOUTSINKS | FDA UDI | Class I | Active |
| InCore TMT | IC-TMT-0101L | FDA UDI | Class I | Active |
| InCore Lapidus | IC-LAP-3552 | FDA UDI | Class II | Unknown |
| InCore Subtalar | ICSUBPGR | FDA UDI | Class I | Active |
| Stratum Ankle | SANLS3534S | FDA UDI | Class II | Active |
| Stratum Ankle | SANLS5026NS | FDA UDI | Class II | Active |
| Stratum | STRM-LK-3564ST | FDA UDI | Class II | Unknown |
| Stratum Ankle | SALS3540S | FDA UDI | Class II | Active |
| Stratum Ankle | SANLS5022S | FDA UDI | Class II | Active |
| InCore Subtalar | ICSUBCASE | FDA UDI | Class I | Active |
| Modus Titanium Osteosynthesis System | K050934 | FDA 510(k) | Class II | Active |
| Aptus Titanium Osteosynthesis System | K051567 | FDA 510(k) | Class II | Active |
| StealthFix Intraosseous Fixation System | K232324 | FDA 510(k) | Class II | Active |
| Modus Imf Screws 2.0 | K052061 | FDA 510(k) | Class II | Active |
| Modus Modular Distraction Osteogenesis System | K051946 | FDA 510(k) | Class II | Active |
Related Companies
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No authorised representatives on record.
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Medartis Inc. has two FDA recall records on file, with the earliest initiated on October 1, 2014, and the most recent on April 12, 2024. The records reflect recalls with statuses of open, classified, and terminated. One involved a product with a screw measuring 16mm instead of the specified 22mm length, while the other concerned breakage of the temporary tension bolt in the APTUS Ulna Shortening 2.5 instrument, based on three reported complaints.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 12, 2024 | Z-1821-2024 | — | open, classified | Screw is 16mm long instead of 22mm long. |
| Oct 1, 2014 | Z-0150-2015 | — | terminated | A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. |