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United States·US-MF-000025261
Last updated September 17, 2026
What TORNIER, INC. makes
Tornier, Inc. manufactures orthopaedic devices including non-sliding bone screws, reusable surgical implant templates, and total reverse shoulder prostheses. Their portfolio covers metallic and polyethylene components for shoulder replacements, such as stem-fixed humeral heads, reverse shoulder cups, and coated humeral stems. The company also produces reusable orthopaedic tools like bone-reaming instruments and positioning guides for prosthesis implantation.
The company’s devices are classified under FDA regulations as Class I and Class II, with listings in the FDA’s Unique Device Identifier (UDI) database. Products are designed for orthopaedic applications and comply with relevant US regulatory requirements. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Tornier, Inc. manufacture?
Tornier, Inc. specializes in orthopaedic devices, primarily focusing on shoulder and bone-related solutions. Their portfolio includes non-sliding orthopaedic bone screws, reusable surgical implant templates, and a range of shoulder prostheses such as total reverse shoulder systems, stem-fixed metallic humeral heads, polyethylene reverse shoulder cups, and coated humeral stems. They also produce reusable orthopaedic tools like bone-reaming instruments and positioning guides for prosthesis implantation, all designed for orthopaedic surgical procedures.
Where is Tornier, Inc. based, and what does that mean for their regulatory compliance?
Tornier, Inc. is based in the United States, which means their devices are subject to FDA regulations. Since they operate domestically, their products must comply with US regulatory requirements, including classification under FDA categories (Class I or Class II) and potential listing in the FDA’s Unique Device Identifier (UDI) database. This ensures their devices meet the necessary standards for safety, performance, and quality before entering the market.
Which regulatory registries or databases list Tornier, Inc.’s devices?
Tornier, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and clinical purposes. Listing in the UDI database is a requirement for certain Class I and Class II devices under FDA regulations.
How are Tornier, Inc.’s orthopaedic devices classified under FDA regulations?
Tornier, Inc.’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as shoulder prostheses or bone screws, which fall into these categories due to their surgical applications.
What does it mean for Tornier, Inc.’s devices to be listed in the FDA’s UDI database?
Listing in the FDA’s Unique Device Identifier (UDI) database means each of Tornier, Inc.’s devices has a unique code assigned to it, combining a device identifier and a production identifier. This helps distinguish between similar products, track recalls, and ensure accurate reporting of adverse events. The UDI system improves transparency in the medical device supply chain, benefiting healthcare providers, regulators, and patients by ensuring proper identification and accountability of devices in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 10801 , Nesbitt Avenue South, Minnesota, United States
- Website
- www.stryker.com
- —
- —
- [email protected]
- Phone
- +1-6124715641
- PRRC Contact
- Jeanine Redden
- EUDAMED SRN
- US-MF-000025261
- FDA FEI Number
- 3000718467
- DUNS Number
- 968990812
Catalogue (8054)
Page 51 of 162| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tornier HRS | ARS980929 | FDA UDI | Class II | Active |
| Tornier Perform™ Humeral System | DWR1396 | FDA UDI | Class II | Active |
| MaxTorque™ | MSD-010-55-475P | FDA UDI | Class II | Unknown |
| MaxLock Extreme™ | TMT-002-23SL | FDA UDI | Class II | Active |
| Aequalis™ Flex Revive™ | ARS980908 | FDA UDI | Class II | Active |
| Tornier Perform | MWE095 | FDA UDI | Class I | Active |
| Aequalis™ Fx2 | DWK132B | FDA UDI | Class II | Unknown |
| Aequalis™ Ascend™ Flex | DWF618B | FDA UDI | Class II | Active |
| Simpliciti™ | 7122877 | FDA UDI | Class II | Active |
| Salto Xt | LJV180 | FDA UDI | Class II | Unknown |
| Tornier Flex Shoulder System | DWG056 | FDA UDI | Class II | Active |
| Tornier Perform | MWR1330 | FDA UDI | Class I | Active |
| Tornier Perform Humeral System | IFX509 | FDA UDI | Class II | Active |
| Tornier Perform | MWH643 | FDA UDI | Class I | Active |
| WAVE Calcaneal Fracture Plate™ | ZPCS44 | FDA UDI | Class II | Unknown |
| CalcLock™ | CAT-021-35-325 | FDA UDI | Class II | Unknown |
| Tornier Perform | MWH676 | FDA UDI | Class I | Active |
| Ortholoc™ Sps | SPS354 | FDA UDI | Class II | Active |
| ForeFoot STP | FHS-010-20-28L | FDA UDI | Class II | Unknown |
| Tornier Perform | MWP1360 | FDA UDI | Class I | Active |
| 611 - Ankle Fusion Nail | VJU065 | FDA UDI | Class II | Unknown |
| Aequalis Reversed | DWD038 | FDA UDI | Class II | Active |
| Perform™ Humeral System | DWN4615 | FDA UDI | Class II | Active |
| Aequalis™ Flex Revive™ | ARS980922 | FDA UDI | Class II | Active |
| Latitude™ - Elbow | DKY208 | FDA UDI | Class II | Active |
| Aequalis™ Adjustable Reversed | 6121510 | FDA UDI | Class II | Active |
| MaxLock Extreme™ | VAR-031-35-42 | FDA UDI | Class II | Active |
| WAVE Calcaneal Fracture Plate™ | ZPFTS60 | FDA UDI | Class II | Unknown |
| Affiniti™ | 0020049 | FDA UDI | Class II | Unknown |
| Ortholoc SPS | MHP031 | FDA UDI | Class I | Active |
| Aequalis™ Fx2 | DWK144B | FDA UDI | Class II | Unknown |
| Aequalis™ Flex Revive™ | ARS742403 | FDA UDI | Class II | Active |
| Aequalis™ Flex Revive™ | ARS342005 | FDA UDI | Class II | Active |
| CalcLock™ | CAT-011-40P-50 | FDA UDI | Class II | Active |
| Affiniti | 9723091 | FDA UDI | Class I | Active |
| Tornier HRS | ARS342008 | FDA UDI | Class II | Active |
| Tornier Perform® Anatomic Augmented Glenoid | DWK403RA35S | FDA UDI | Class II | Active |
| Tornier Perform™ Humeral System | DWR4390 | FDA UDI | Class II | Active |
| Tornier Perform™ Humeral System | DWN4113 | FDA UDI | Class II | Active |
| MaxLock Extreme™ | MCS-002-NL | FDA UDI | Class II | Active |
| Tornier Perform | MWN4615 | FDA UDI | Class I | Active |
| Ortholoc™ Sps | SPS324 | FDA UDI | Class II | Active |
| Tornier Flex | MWF051 | FDA UDI | Class I | Active |
| Tornier Long Humeral Nail | DHN5796 | FDA UDI | Class II | Active |
| Aequalis™ Flex Revive™ | ARS342001 | FDA UDI | Class II | Active |
| Perform™ Humeral System | DWR2366 | FDA UDI | Class II | Active |
| Tornier Perform Humeral System | ARS1023805 | FDA UDI | Class I | Active |
| Perform™ Humeral System | DWT4363 | FDA UDI | Class II | Active |
| Tornier Perform™ Humeral System | DWX3PL | FDA UDI | Class II | Active |
| Ortholoc SPS | MHP021 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Tornier SAS FR