{
  "companyId": "47682",
  "slug": "howmedica-osteonics-corp-47682",
  "name": "Howmedica Osteonics Corp.",
  "clearances": {
    "total": 335,
    "last12Months": 4,
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    "latest": "2026-07-10"
  },
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  "productCodeCount": 49,
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        "resNumber": "Z-2461-2026",
        "productCode": "MBH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-05-19",
        "reason": "Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB)."
      },
      {
        "resNumber": "Z-2462-2026",
        "productCode": "MBH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-05-19",
        "reason": "Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB)."
      },
      {
        "resNumber": "Z-1572-2026",
        "productCode": "OLO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-02",
        "reason": "A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment."
      },
      {
        "resNumber": "Z-0963-2026",
        "productCode": "HAW",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-11-12",
        "reason": "When the device is activated during surgery, the device software issues an error message \"Instrument Face Mask (6001385000000) is not valid for this application\" resulting in an inability to use the device."
      },
      {
        "resNumber": "Z-2640-2025",
        "productCode": "JDI",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-08-28",
        "reason": "a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted."
      }
    ]
  },
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    "countries": [
      "US"
    ]
  },
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    {
      "code": "HSB",
      "deviceName": "Rod, Fixation, Intramedullary And Accessories",
      "clearances": 39,
      "latest": "2012-02-15",
      "medianReviewDays": 28
    },
    {
      "code": "JWH",
      "deviceName": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",
      "clearances": 36,
      "latest": "2025-02-06",
      "medianReviewDays": 76
    },
    {
      "code": "LZO",
      "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented",
      "clearances": 27,
      "latest": "2024-04-24",
      "medianReviewDays": 53
    },
    {
      "code": "LPH",
      "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",
      "clearances": 22,
      "latest": "2026-07-10",
      "medianReviewDays": 89
    },
    {
      "code": "HRS",
      "deviceName": "Plate, Fixation, Bone",
      "clearances": 21,
      "latest": "2012-10-01",
      "medianReviewDays": 51
    },
    {
      "code": "JDI",
      "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented",
      "clearances": 21,
      "latest": "2024-08-02",
      "medianReviewDays": 59
    },
    {
      "code": "KTT",
      "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component",
      "clearances": 19,
      "latest": "2009-10-08",
      "medianReviewDays": 55
    },
    {
      "code": "MEH",
      "deviceName": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate",
      "clearances": 19,
      "latest": "2013-02-01",
      "medianReviewDays": 60
    },
    {
      "code": "KRO",
      "deviceName": "Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer",
      "clearances": 13,
      "latest": "2025-12-15",
      "medianReviewDays": 86
    },
    {
      "code": "MBH",
      "deviceName": "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer",
      "clearances": 11,
      "latest": "2026-02-18",
      "medianReviewDays": 70
    },
    {
      "code": "KWQ",
      "deviceName": "Appliance, Fixation, Spinal Intervertebral Body",
      "clearances": 10,
      "latest": "2003-08-08",
      "medianReviewDays": 30
    },
    {
      "code": "LXT",
      "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite",
      "clearances": 9,
      "latest": "2005-06-17",
      "medianReviewDays": 36
    },
    {
      "code": "MNH",
      "deviceName": "Orthosis, Spondylolisthesis Spinal Fixation",
      "clearances": 9,
      "latest": "2003-12-10",
      "medianReviewDays": 28
    },
    {
      "code": "KWP",
      "deviceName": "Appliance, Fixation, Spinal Interlaminal",
      "clearances": 7,
      "latest": "2003-07-17",
      "medianReviewDays": 30
    },
    {
      "code": "HSD",
      "deviceName": "Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented",
      "clearances": 6,
      "latest": "2007-05-04",
      "medianReviewDays": 29
    },
    {
      "code": "HWC",
      "deviceName": "Screw, Fixation, Bone",
      "clearances": 5,
      "latest": "2007-05-11",
      "medianReviewDays": 23
    },
    {
      "code": "KRR",
      "deviceName": "Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer",
      "clearances": 5,
      "latest": "2021-06-04",
      "medianReviewDays": 36
    },
    {
      "code": "MNI",
      "deviceName": "Orthosis, Spinal Pedicle Fixation",
      "clearances": 5,
      "latest": "2004-02-20",
      "medianReviewDays": 45
    },
    {
      "code": "KWL",
      "deviceName": "Prosthesis, Hip, Hemi-, Femoral, Metal",
      "clearances": 4,
      "latest": "2022-10-21",
      "medianReviewDays": 30
    },
    {
      "code": "KWS",
      "deviceName": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",
      "clearances": 4,
      "latest": "2011-05-05",
      "medianReviewDays": 33
    },
    {
      "code": "KWZ",
      "deviceName": "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer",
      "clearances": 4,
      "latest": "2007-03-08",
      "medianReviewDays": 104
    },
    {
      "code": "MQV",
      "deviceName": "Filler, Bone Void, Calcium Compound",
      "clearances": 3,
      "latest": "2004-03-09",
      "medianReviewDays": 90
    },
    {
      "code": "HRY",
      "deviceName": "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer",
      "clearances": 2,
      "latest": "2008-10-03",
      "medianReviewDays": 29
    },
    {
      "code": "HSX",
      "deviceName": "Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer",
      "clearances": 2,
      "latest": "2004-02-13",
      "medianReviewDays": 72
    },
    {
      "code": "HTY",
      "deviceName": "Pin, Fixation, Smooth",
      "clearances": 2,
      "latest": "2010-04-02",
      "medianReviewDays": 60
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  "productCodesTotal": "49",
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    {
      "kNumber": "K261624",
      "deviceName": "Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component",
      "productCode": "LPH",
      "decisionDate": "2026-07-10",
      "reviewDays": 56
    },
    {
      "kNumber": "K253637",
      "deviceName": "Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert",
      "productCode": "MBH",
      "decisionDate": "2026-02-18",
      "reviewDays": 91
    },
    {
      "kNumber": "K252898",
      "deviceName": "Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper",
      "productCode": "KRO",
      "decisionDate": "2025-12-15",
      "reviewDays": 95
    },
    {
      "kNumber": "K252044",
      "deviceName": "Triathlon® Total Knee System - Triathlon® Gold Femoral Components",
      "productCode": "MBH",
      "decisionDate": "2025-10-24",
      "reviewDays": 116
    },
    {
      "kNumber": "K251665",
      "deviceName": "Triathlon® Hinge Knee System",
      "productCode": "KRO",
      "decisionDate": "2025-07-25",
      "reviewDays": 56
    },
    {
      "kNumber": "K250989",
      "deviceName": "Stryker and Serf hip devices",
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      "decisionDate": "2025-07-25",
      "reviewDays": 116
    },
    {
      "kNumber": "K243817",
      "deviceName": "Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert",
      "productCode": "JWH",
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    },
    {
      "kNumber": "K243784",
      "deviceName": "Stryker Orthopaedics Hip Devices Labeling Update",
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      "reviewDays": 59
    },
    {
      "kNumber": "K242831",
      "deviceName": "Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System",
      "productCode": "JWH",
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    {
      "kNumber": "K241716",
      "deviceName": "Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component",
      "productCode": "JDI",
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        "name": "HOWMEDICA OSTEONICS CORP",
        "dataset": "device/registrationlisting",
        "method": "normalised"
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      {
        "name": "Howmedica Osteonics",
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        "method": "normalised"
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      {
        "name": "Howmedica Osteonics Corp",
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        "method": "normalised"
      },
      {
        "name": "Howmedica Osteonics Corp (Dba Stryker Orthopaedics)",
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        "method": "normalised"
      },
      {
        "name": "Howmedica Osteonics Corp dba Stryker Craniomaxillofacial",
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        "method": "normalised"
      },
      {
        "name": "Howmedica Osteonics Corp.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Howmedica Osteonics Corp.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Howmedica Osteonics Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Howmedica%20Osteonics%20Corp.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Howmedica%20Osteonics%20Corp.%22"
  },
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      "loadedAt": "2026-08-10T19:40:09Z",
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    {
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      "loadedAt": "2026-08-10T06:54:18Z",
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      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
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  "retrievedAt": "2026-08-11T14:48:53.023Z"
}