{
  "companyId": "52479",
  "slug": "synthes-usa-52479",
  "name": "Synthes USA",
  "clearances": {
    "total": 418,
    "last12Months": 0,
    "first": "1977-03-10",
    "latest": "2018-12-21"
  },
  "medianReviewDays": 78,
  "productCodeCount": 56,
  "recalls": {
    "total": 4,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0617-2018",
        "productCode": "OIS",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2017-08-10",
        "reason": "The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit."
      },
      {
        "resNumber": "Z-0618-2018",
        "productCode": "MQV",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2017-08-10",
        "reason": "The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit."
      },
      {
        "resNumber": "Z-0460-2012",
        "productCode": "MQV",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2011-09-29",
        "reason": "A recent shipment carrying Norian SRS was lost by the carrier.  Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements.  The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements."
      },
      {
        "resNumber": "Z-0792-06",
        "productCode": "JEY",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2006-03-30",
        "reason": "Integrity of outer mylar pouch could be compromised,  possibly rendering the exterior of the inner foil pouch unsterile."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "HRS",
      "deviceName": "Plate, Fixation, Bone",
      "clearances": 95,
      "latest": "2018-12-21",
      "medianReviewDays": 75
    },
    {
      "code": "JEY",
      "deviceName": "Plate, Bone",
      "clearances": 38,
      "latest": "2010-12-20",
      "medianReviewDays": 82
    },
    {
      "code": "KTT",
      "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component",
      "clearances": 32,
      "latest": "2016-11-10",
      "medianReviewDays": 64
    },
    {
      "code": "HWC",
      "deviceName": "Screw, Fixation, Bone",
      "clearances": 31,
      "latest": "2011-07-25",
      "medianReviewDays": 78
    },
    {
      "code": "HSB",
      "deviceName": "Rod, Fixation, Intramedullary And Accessories",
      "clearances": 23,
      "latest": "2014-03-31",
      "medianReviewDays": 87
    },
    {
      "code": "KWP",
      "deviceName": "Appliance, Fixation, Spinal Interlaminal",
      "clearances": 17,
      "latest": "2009-07-10",
      "medianReviewDays": 69
    },
    {
      "code": "LXT",
      "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite",
      "clearances": 14,
      "latest": "2008-01-29",
      "medianReviewDays": 71
    },
    {
      "code": "DZL",
      "deviceName": "Screw, Fixation, Intraosseous",
      "clearances": 13,
      "latest": "2010-01-25",
      "medianReviewDays": 71
    },
    {
      "code": "KWQ",
      "deviceName": "Appliance, Fixation, Spinal Intervertebral Body",
      "clearances": 13,
      "latest": "2015-12-02",
      "medianReviewDays": 164
    },
    {
      "code": "MQN",
      "deviceName": "External Mandibular Fixator And/Or Distractor",
      "clearances": 12,
      "latest": "2008-05-14",
      "medianReviewDays": 78
    },
    {
      "code": "JDS",
      "deviceName": "Nail, Fixation, Bone",
      "clearances": 11,
      "latest": "2011-12-05",
      "medianReviewDays": 59
    },
    {
      "code": "JDQ",
      "deviceName": "Cerclage, Fixation",
      "clearances": 8,
      "latest": "2011-07-28",
      "medianReviewDays": 67
    },
    {
      "code": "KTW",
      "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Single Component",
      "clearances": 8,
      "latest": "2008-03-20",
      "medianReviewDays": 65
    },
    {
      "code": "MQV",
      "deviceName": "Filler, Bone Void, Calcium Compound",
      "clearances": 8,
      "latest": "2007-10-23",
      "medianReviewDays": 33
    },
    {
      "code": "MNH",
      "deviceName": "Orthosis, Spondylolisthesis Spinal Fixation",
      "clearances": 6,
      "latest": "1999-06-02",
      "medianReviewDays": 136
    },
    {
      "code": "HTN",
      "deviceName": "Washer, Bolt Nut",
      "clearances": 5,
      "latest": "2002-02-08",
      "medianReviewDays": 85
    },
    {
      "code": "HTY",
      "deviceName": "Pin, Fixation, Smooth",
      "clearances": 5,
      "latest": "2001-04-09",
      "medianReviewDays": 84
    },
    {
      "code": "JDO",
      "deviceName": "Device, Fixation, Proximal Femoral, Implant",
      "clearances": 5,
      "latest": "1998-07-17",
      "medianReviewDays": 84
    },
    {
      "code": "MNI",
      "deviceName": "Orthosis, Spinal Pedicle Fixation",
      "clearances": 5,
      "latest": "2003-03-24",
      "medianReviewDays": 90
    },
    {
      "code": "GXN",
      "deviceName": "Plate, Cranioplasty, Preformed, Non-Alterable",
      "clearances": 4,
      "latest": "2005-12-14",
      "medianReviewDays": 35
    },
    {
      "code": "GXP",
      "deviceName": "Methyl Methacrylate For Cranioplasty",
      "clearances": 4,
      "latest": "2006-04-13",
      "medianReviewDays": 51
    },
    {
      "code": "GXR",
      "deviceName": "Cover, Burr Hole",
      "clearances": 4,
      "latest": "2004-11-17",
      "medianReviewDays": 72
    },
    {
      "code": "JDW",
      "deviceName": "Pin, Fixation, Threaded",
      "clearances": 4,
      "latest": "2004-04-12",
      "medianReviewDays": 59
    },
    {
      "code": "JEC",
      "deviceName": "Component, Traction, Invasive",
      "clearances": 4,
      "latest": "2007-08-24",
      "medianReviewDays": 87
    },
    {
      "code": "MQP",
      "deviceName": "Spinal Vertebral Body Replacement Device",
      "clearances": 4,
      "latest": "2003-03-17",
      "medianReviewDays": 89
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "56",
  "recentClearances": [
    {
      "kNumber": "K180821",
      "deviceName": "TruMatch Graft Cage - Long Bone",
      "productCode": "HRS",
      "decisionDate": "2018-12-21",
      "reviewDays": 266
    },
    {
      "kNumber": "K161417",
      "deviceName": "DePuy Synthes MAXFRAME Multi-Axial Correction System",
      "productCode": "KTT",
      "decisionDate": "2016-11-10",
      "reviewDays": 171
    },
    {
      "kNumber": "K152239",
      "deviceName": "Zero-P Natural Plate System",
      "productCode": "KWQ",
      "decisionDate": "2015-12-02",
      "reviewDays": 114
    },
    {
      "kNumber": "K141527",
      "deviceName": "DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM",
      "productCode": "HRS",
      "decisionDate": "2015-03-30",
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    },
    {
      "kNumber": "K131984",
      "deviceName": "SYNTHES SYNSONIC ULNA NAIL",
      "productCode": "HSB",
      "decisionDate": "2014-03-31",
      "reviewDays": 276
    },
    {
      "kNumber": "K130146",
      "deviceName": "SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM",
      "productCode": "NDN",
      "decisionDate": "2013-05-20",
      "reviewDays": 118
    },
    {
      "kNumber": "K121601",
      "deviceName": "SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE",
      "productCode": "HRS",
      "decisionDate": "2012-07-06",
      "reviewDays": 35
    },
    {
      "kNumber": "K112030",
      "deviceName": "SYNTHES RADIAL HEAD PROSTHESIS SYSTEM",
      "productCode": "KWI",
      "decisionDate": "2012-06-19",
      "reviewDays": 340
    },
    {
      "kNumber": "K120854",
      "deviceName": "SYNTHES VA LCP ANKLE TRAUMA SYSTEM",
      "productCode": "HRS",
      "decisionDate": "2012-06-18",
      "reviewDays": 89
    },
    {
      "kNumber": "K120275",
      "deviceName": "SYNTHES ACIS/VERTEBRAL SPACER CR",
      "productCode": "ODP",
      "decisionDate": "2012-05-25",
      "reviewDays": 116
    }
  ],
  "nameVariants": {
    "total": "7",
    "shown": [
      {
        "name": "Synthes (USA)",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Synthes (Usa)",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Synthes (Usa), LLC",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Synthes USA",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Synthes USA",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Synthes USA",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Synthes USA, LLC",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Synthes%20USA%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Synthes%20USA%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
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      "loadedAt": "2026-08-10T19:40:12Z",
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    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
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    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.022Z"
}