{
  "companyId": "53658",
  "slug": "tornier-inc-53658",
  "name": "Tornier, Inc.",
  "clearances": {
    "total": 96,
    "last12Months": 3,
    "first": "1995-09-27",
    "latest": "2026-07-22"
  },
  "medianReviewDays": 101,
  "productCodeCount": 23,
  "recalls": {
    "total": 20,
    "openLast12Months": 2,
    "recent": [
      {
        "resNumber": "Z-1769-2026",
        "productCode": "KWS",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-05",
        "reason": "Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system."
      },
      {
        "resNumber": "Z-1237-2026",
        "productCode": "KWS",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-12-19",
        "reason": "A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery."
      },
      {
        "resNumber": "Z-1651-2025",
        "productCode": "JDB",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-03-03",
        "reason": "A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking.\n\"\tLaser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect)\n\"\tDevice Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)"
      },
      {
        "resNumber": "Z-3155-2024",
        "productCode": "PKC",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-08-29",
        "reason": "One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device)."
      },
      {
        "resNumber": "Z-3309-2024",
        "productCode": "PAO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-08-29",
        "reason": "Devices from one lot of Perform\" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer."
      }
    ]
  },
  "registration": {
    "sites": 3,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "KWS",
      "deviceName": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",
      "clearances": 24,
      "latest": "2026-07-22",
      "medianReviewDays": 45
    },
    {
      "code": "PHX",
      "deviceName": "Shoulder Prosthesis, Reverse Configuration",
      "clearances": 18,
      "latest": "2026-01-08",
      "medianReviewDays": 97
    },
    {
      "code": "JDB",
      "deviceName": "Prosthesis, Elbow, Semi-Constrained, Cemented",
      "clearances": 9,
      "latest": "2020-08-05",
      "medianReviewDays": 108
    },
    {
      "code": "MBI",
      "deviceName": "Fastener, Fixation, Nondegradable, Soft Tissue",
      "clearances": 7,
      "latest": "2015-07-28",
      "medianReviewDays": 90
    },
    {
      "code": "HRS",
      "deviceName": "Plate, Fixation, Bone",
      "clearances": 4,
      "latest": "2019-07-17",
      "medianReviewDays": 112
    },
    {
      "code": "FTL",
      "deviceName": "Mesh, Surgical, Polymeric",
      "clearances": 3,
      "latest": "2012-01-25",
      "medianReviewDays": 228
    },
    {
      "code": "HSB",
      "deviceName": "Rod, Fixation, Intramedullary And Accessories",
      "clearances": 3,
      "latest": "2023-10-31",
      "medianReviewDays": 130
    },
    {
      "code": "HSD",
      "deviceName": "Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented",
      "clearances": 3,
      "latest": "2006-12-22",
      "medianReviewDays": 30
    },
    {
      "code": "JWH",
      "deviceName": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",
      "clearances": 3,
      "latest": "2011-05-05",
      "medianReviewDays": 233
    },
    {
      "code": "HSN",
      "deviceName": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer",
      "clearances": 2,
      "latest": "2009-03-17",
      "medianReviewDays": 64
    },
    {
      "code": "HSX",
      "deviceName": "Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer",
      "clearances": 2,
      "latest": "2012-07-25",
      "medianReviewDays": 180
    },
    {
      "code": "HWC",
      "deviceName": "Screw, Fixation, Bone",
      "clearances": 2,
      "latest": "2015-08-04",
      "medianReviewDays": 125
    },
    {
      "code": "JDI",
      "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented",
      "clearances": 2,
      "latest": "2000-07-20",
      "medianReviewDays": 24
    },
    {
      "code": "KTT",
      "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component",
      "clearances": 2,
      "latest": "2006-12-22",
      "medianReviewDays": 28
    },
    {
      "code": "MAI",
      "deviceName": "Fastener, Fixation, Biodegradable, Soft Tissue",
      "clearances": 2,
      "latest": "2013-05-13",
      "medianReviewDays": 99
    },
    {
      "code": "NWJ",
      "deviceName": "Suture, Recombinant Technology",
      "clearances": 2,
      "latest": "2013-04-04",
      "medianReviewDays": 33
    },
    {
      "code": "PKC",
      "deviceName": "Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained",
      "clearances": 2,
      "latest": "2022-09-14",
      "medianReviewDays": 79
    },
    {
      "code": "JDC",
      "deviceName": "Prosthesis, Elbow, Constrained, Cemented",
      "clearances": 1,
      "latest": "2000-10-02",
      "medianReviewDays": 273
    },
    {
      "code": "KRR",
      "deviceName": "Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer",
      "clearances": 1,
      "latest": "2012-02-23",
      "medianReviewDays": 227
    },
    {
      "code": "KWI",
      "deviceName": "Prosthesis, Elbow, Hemi-, Radial, Polymer",
      "clearances": 1,
      "latest": "2000-08-31",
      "medianReviewDays": 276
    },
    {
      "code": "KWT",
      "deviceName": "Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented",
      "clearances": 1,
      "latest": "2025-10-30",
      "medianReviewDays": 150
    },
    {
      "code": "LZN",
      "deviceName": "Cement Obturator",
      "clearances": 1,
      "latest": "2006-09-14",
      "medianReviewDays": 78
    },
    {
      "code": "PAO",
      "deviceName": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented",
      "clearances": 1,
      "latest": "2020-09-11",
      "medianReviewDays": 116
    }
  ],
  "productCodesShown": 23,
  "productCodesTotal": "23",
  "recentClearances": [
    {
      "kNumber": "K260721",
      "deviceName": "Tornier Perform Advanced Glenoid",
      "productCode": "KWS",
      "decisionDate": "2026-07-22",
      "reviewDays": 139
    },
    {
      "kNumber": "K252788",
      "deviceName": "Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)",
      "productCode": "PHX",
      "decisionDate": "2026-01-08",
      "reviewDays": 128
    },
    {
      "kNumber": "K251686",
      "deviceName": "Tornier Humeral Reconstruction System Max (Tornier HRS Max)",
      "productCode": "KWT",
      "decisionDate": "2025-10-30",
      "reviewDays": 150
    },
    {
      "kNumber": "K230352",
      "deviceName": "Tornier Humeral Nail and Tornier Long Humeral Nail",
      "productCode": "HSB",
      "decisionDate": "2023-10-31",
      "reviewDays": 264
    },
    {
      "kNumber": "K220914",
      "deviceName": "Tornier Perform Humeral System – Fracture",
      "productCode": "PHX",
      "decisionDate": "2022-10-14",
      "reviewDays": 198
    },
    {
      "kNumber": "K220418",
      "deviceName": "Tornier Perform Humeral System – Stemless",
      "productCode": "PKC",
      "decisionDate": "2022-09-14",
      "reviewDays": 212
    },
    {
      "kNumber": "K211359",
      "deviceName": "Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation",
      "productCode": "PHX",
      "decisionDate": "2021-11-12",
      "reviewDays": 193
    },
    {
      "kNumber": "K213124",
      "deviceName": "Tomier Perform™ Reversed Glenoid Cannulated Glenospheres",
      "productCode": "PHX",
      "decisionDate": "2021-10-26",
      "reviewDays": 29
    },
    {
      "kNumber": "K201315",
      "deviceName": "PERFORM Humeral System – Stem",
      "productCode": "PAO",
      "decisionDate": "2020-09-11",
      "reviewDays": 116
    },
    {
      "kNumber": "K193247",
      "deviceName": "LATITUDE EV™ Total Elbow Arthroplasty",
      "productCode": "JDB",
      "decisionDate": "2020-08-05",
      "reviewDays": 254
    }
  ],
  "nameVariants": {
    "total": "8",
    "shown": [
      {
        "name": "TORNIER Inc.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "TORNIER, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "TORNIER, SAS",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Tornier",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Tornier, Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Tornier, Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Tornier, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Tornier, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Tornier%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Tornier%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.047Z"
}