Data / Medical devices / United States / TORNIER Inc.
TORNIER Inc.: FDA-registered device maker in Columbia City, IN, United States, 67 510(k) clearances
TORNIER Inc. is registered with the FDA (registration 3004983210) in Columbia City, IN, United States. It lists 60 device types. The FDA files 67 510(k) clearances under its listings, the newest dated July 22, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004983210
- Address
- 4375 E. Park 30 Drive, Columbia City, IN, United States, 46725
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Specification developer
- First device listed
- June 9, 1986
- Registered through
- 2027
- Brand names listed
- 10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10mm SUBFIX TRIAL, 11.5MM FLEXIBLE REAMER, 11.5mm SUBFIX TRIAL, 11MM FLEXIBLE REAMER, 12MM FLEXIBLE REAMER, 135 mm Reusable Slat, SE Retr, 10 Pack 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 |
|---|---|---|---|---|---|---|
| July 22, 2026 | K260721 | Tornier Perform Advanced Glenoid | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 12, 2026 | K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | PHX | Substantially Equivalent | Stryker Corporation (Tornier, Inc.) | accessdata.fda.gov |
| October 30, 2025 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | KWT | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| December 6, 2024 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | KWS | Substantially Equivalent | Stryker Corporation (Tornier, Inc.) | accessdata.fda.gov |
| February 21, 2024 | K232265 | BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| October 31, 2023 | K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | HSB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 14, 2022 | K220914 | Tornier Perform Humeral System Fracture | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 14, 2022 | K220418 | Tornier Perform Humeral System Stemless | PKC | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| November 12, 2021 | K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 26, 2021 | K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 11, 2020 | K201315 | PERFORM Humeral System Stem | PAO | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| August 5, 2020 | K193247 | LATITUDE EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| July 17, 2019 | K191711 | ORTHOLOC SPS Shoulder Plating System | HRS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 14, 2019 | K191318 | AEQUALIS FLEX REVIVE Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| January 30, 2019 | K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| December 27, 2018 | K182461 | LATITUDE EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 5, 2018 | K181587 | ORTHOLOC SPS Shoulder Plating System | HRS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 20, 2018 | K181420 | Aequalis Flex Revive Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| August 31, 2017 | K171010 | Latitude EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| November 15, 2016 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 10, 2016 | K160975 | Aequalis PerFORM+ Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 23, 2015 | K150583 | Aequalis PerFORM+ Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| March 4, 2015 | K143552 | Simpliciti Shoulder System | PKC | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| August 21, 2014 | K142148 | ORTHOHELIX STAPLE SYSTEM | JDR | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| August 21, 2014 | K141004 | INTRAOSSEOUS FIXATION SYSTEM | HTY | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| July 11, 2014 | K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 18, 2014 | K141029 | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 4, 2014 | K133777 | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR | MBI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| January 3, 2014 | K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | HTN | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| December 5, 2013 | K133376 | AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT | HSB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 19, 2013 | K132632 | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES | MBI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 17, 2013 | K132591 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| August 15, 2013 | K130832 | ORTHOHELIX STAPLE SYSTEM | JDR | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| May 31, 2013 | K131324 | MAXTORQUE SCREW SYSTEM | HWC | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| May 13, 2013 | K122635 | TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR | MAI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| December 14, 2012 | K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| September 6, 2012 | K122005 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| July 5, 2012 | K120739 | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 13, 2012 | K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| April 17, 2012 | K120165 | INTRAOSSEOUS FIXATION SYSTEM | HTY | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| April 10, 2012 | K120157 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| March 9, 2012 | K113413 | ASCEND SHOULDER SYSTEM | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| January 30, 2012 | K113048 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 6, 2011 | K111041 | MINI VARIABLE SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 2, 2011 | K110773 | TORNIER INSITE FT SUTURE ANCHOR | MBI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 27, 2010 | K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 29, 2010 | K100562 | LATITUDE ELBOW PROSTHESIS | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 20, 2010 | K100618 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| September 21, 2009 | K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM | MBI | Substantially Equivalent | Tornier | accessdata.fda.gov |
| July 2, 2009 | K090582 | CALCANEAL FRACTURE PLATE SYSTEM | HRS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 15, 2009 | K090289 | CLAVICLE PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| January 27, 2009 | K082754 | AEQUALIS HUMERAL NAIL SYSTEM | HSB | Substantially Equivalent | Tornier | accessdata.fda.gov |
| December 8, 2008 | K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| July 17, 2008 | K081707 | AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| March 20, 2008 | K073624 | MODULAR FOOT SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| November 8, 2007 | K072710 | NEXFIX COMPRESSION PIN | JDW | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| August 24, 2007 | K070787 | LATITUDE ELBOW PROTHESIS | JDB | Substantially Equivalent | Tornier | accessdata.fda.gov |
| June 29, 2006 | K061400 | CALCANEAL TRAUMA SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| May 10, 2006 | K060386 | NEXA CARPO METACARPAL IMPLANT | KYI | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| March 7, 2006 | K060428 | CSS CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| February 27, 2006 | K053182 | DRLOCK DISTAL RADIUS VOLAR SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| December 22, 2005 | K053408 | NEXA BONE PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| October 27, 2005 | K052754 | WRIST FUSION PLATE | LXT | Substantially Equivalent | Dvo Extremity Solutions, LLC | accessdata.fda.gov |
| September 6, 2005 | K051740 | TAPERED COMPRESSION PIN | JDW | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| October 8, 2004 | K042437 | DORSAL INTRAMEDULLARY PLATE | HRS | Substantially Equivalent | Deo Volente Orthopaedics, LLC | accessdata.fda.gov |
| December 15, 2003 | K032902 | SUBTALAR ARTHRORISIS IMPLANT | HWC | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| April 29, 1999 | K990804 | STAYFUSE | HWC | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
Compare with other makers
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- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Updated July 22, 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.