{
  "code": "HRX",
  "deviceName": "Arthroscope",
  "deviceClass": "II",
  "regulationNumber": "888.1100",
  "panel": "Orthopedic",
  "definition": "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 681,
    "last12Months": 10
  },
  "adverseEvents": {
    "total": 6121,
    "last12Months": 1266
  },
  "reviewDays": {
    "median": 89,
    "sampleSize": 681
  },
  "recalls": {
    "total": 126,
    "recent": [
      {
        "resNumber": "Z-1453-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.",
        "initiated": "2025-02-11"
      },
      {
        "resNumber": "Z-0526-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Karl Storz Endoscopy",
        "firmAsPublished": "Karl Storz Endoscopy",
        "reason": "Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.",
        "initiated": "2024-10-11"
      },
      {
        "resNumber": "Z-2243-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "WOM World of Medicine AG",
        "firmAsPublished": "WOM World Of Medicine AG",
        "reason": "Incorrect transponder data was written on the RFID tags\ntriggers the error message E03, Tube Set lnvalid, may result in a delay of surgery",
        "initiated": "2024-05-24"
      },
      {
        "resNumber": "Z-3053-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
        "initiated": "2024-04-08"
      },
      {
        "resNumber": "Z-0144-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "ADRIA SRL",
        "firmAsPublished": "ADRIA SRL",
        "reason": "The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.",
        "initiated": "2021-05-17"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252790",
      "deviceName": "Digital ClarusScope System and Digital NeuroPEN System",
      "applicant": "Clarus Medical, LLC",
      "company": "Clarus Medical, Llc",
      "decisionDate": "2026-05-26",
      "dateReceived": "2025-09-02"
    },
    {
      "kNumber": "K253523",
      "deviceName": "Freedom DS™ Decompression System",
      "applicant": "Spinal Simplicity",
      "company": "Spinal Simplicity, LLC",
      "decisionDate": "2026-04-16",
      "dateReceived": "2025-11-13"
    },
    {
      "kNumber": "K252546",
      "deviceName": "VantageTM Lumbar Decompression Kit",
      "applicant": "Allevion Medical, LLC",
      "company": "Allevion Medical, LLC",
      "decisionDate": "2026-03-12",
      "dateReceived": "2025-08-12"
    },
    {
      "kNumber": "K253217",
      "deviceName": "MiiS Horus Arthroscope  (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)",
      "applicant": "Medimaging Integrated Solution, Inc (Miis)",
      "company": "Medimaging Integrated Solution, Inc (Miis)",
      "decisionDate": "2025-12-23",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K250795",
      "deviceName": "PUREVUE™ FMS",
      "applicant": "W.O.M. World of Medicine GmbH",
      "company": "W.O.M. World of Medicine GmbH",
      "decisionDate": "2025-12-05",
      "dateReceived": "2025-03-14"
    },
    {
      "kNumber": "K252666",
      "deviceName": "Articulator Arthroscopic Bur",
      "applicant": "Joint Preservation Innovations, LLC",
      "company": "Joint Preservation Innovations, LLC",
      "decisionDate": "2025-11-21",
      "dateReceived": "2025-08-25"
    },
    {
      "kNumber": "K252458",
      "deviceName": "Kyphoplasty Balloon Dilatation Catheters",
      "applicant": "Shanghai Lange Medtech Co., Ltd.",
      "company": "Shanghai Lange Medtech Co., Ltd.",
      "decisionDate": "2025-11-03",
      "dateReceived": "2025-08-05"
    },
    {
      "kNumber": "K252020",
      "deviceName": "TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly",
      "applicant": "Hand Biomechanics Lab, Inc.",
      "company": "Hand Biomechanics Lab Inc",
      "decisionDate": "2025-10-15",
      "dateReceived": "2025-06-30"
    },
    {
      "kNumber": "K252594",
      "deviceName": "UltraGuideCTR® image guided soft tissue release system",
      "applicant": "Sonex Health",
      "company": "SONEX HEALTH LLC",
      "decisionDate": "2025-09-29",
      "dateReceived": "2025-08-15"
    },
    {
      "kNumber": "K243774",
      "deviceName": "ELID (Endoscopic Less Invasive Decompression) System",
      "applicant": "Lesspine Innovations",
      "company": "Lesspine Innovations",
      "decisionDate": "2025-08-27",
      "dateReceived": "2024-12-06"
    }
  ],
  "topApplicants": [
    {
      "name": "KARL STORZ Endoscopy-America, Inc.",
      "count": 28
    },
    {
      "name": "Arthrex, Inc.",
      "count": 27
    },
    {
      "name": "Acufex Microsurgical, Inc.",
      "count": 26
    },
    {
      "name": "Linvatec Corp.",
      "count": 19
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Karl Storz Endoscopy America Inc",
      "count": 28,
      "spellings": 1
    },
    {
      "name": "Arthrex, Inc.",
      "count": 27,
      "spellings": 1
    },
    {
      "name": "Acufex Microsurgical, Inc.",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "Linvatec Corp. dba ConMed Linvatec",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 19,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Spinal Simplicity, LLC",
      "since": "2026-04-16",
      "kNumber": "K253523"
    },
    {
      "name": "Allevion Medical, LLC",
      "since": "2026-03-12",
      "kNumber": "K252546"
    },
    {
      "name": "Medimaging Integrated Solution, Inc (Miis)",
      "since": "2025-12-23",
      "kNumber": "K253217"
    },
    {
      "name": "Joint Preservation Innovations, LLC",
      "since": "2025-11-21",
      "kNumber": "K252666"
    },
    {
      "name": "Shanghai Lange Medtech Co., Ltd.",
      "since": "2025-11-03",
      "kNumber": "K252458"
    },
    {
      "name": "SONEX HEALTH LLC",
      "since": "2025-09-29",
      "kNumber": "K252594"
    },
    {
      "name": "Lesspine Innovations",
      "since": "2025-08-27",
      "kNumber": "K243774"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 119,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 152,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 137,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 122,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 144,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 106,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 113,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 180,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 171,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 188,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 188,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 304,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 300,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 158,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 121,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 177,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 198,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 160,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 282,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 222,
        "expectedLow": 68.90510976153834,
        "expectedHigh": 315.3703604833363,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 147,
        "expectedLow": 67.29611260454492,
        "expectedHigh": 282.87372079472834,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 126,
        "expectedLow": 66.18044070370173,
        "expectedHigh": 307.38537888488315,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 196,
        "expectedLow": 43.57742420612419,
        "expectedHigh": 304.8635788056905,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 163,
        "expectedLow": 48.20137256553091,
        "expectedHigh": 293.28127663729737,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 163,
        "expectedLow": 61.73128822972438,
        "expectedHigh": 288.31073813323945,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 182,
        "expectedLow": 144.15067650670971,
        "expectedHigh": 387.3350981131219,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 142,
        "expectedLow": 85.13674761308984,
        "expectedHigh": 277.5573179855149,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 151,
        "expectedLow": 82.48477501307107,
        "expectedHigh": 276.2716477723908,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 187,
        "expectedLow": 68.32823914103595,
        "expectedHigh": 271.38095207004375,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 145,
        "expectedLow": 65.64447507720064,
        "expectedHigh": 249.08964893994042,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 211,
        "expectedLow": 68.44674889732246,
        "expectedHigh": 275.6050420144565,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 136,
        "expectedLow": 120.18662919731153,
        "expectedHigh": 302.59770964810696,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 170,
        "expectedLow": 88.89450656318583,
        "expectedHigh": 228.73544367038778,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 170,
        "expectedLow": 102.73098448113753,
        "expectedHigh": 251.42382043235412,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HRX (Arthroscope) has three findings, most consequential first. 7 first-time filers in the last 12 months, including Spinal Simplicity, LLC and Allevion Medical, LLC (K253523, K252546, K253217, K252666, K252458). Clearances are running 20% slower — a median 107 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days) (HRX:review_time:12m). The code is crowded, scoring 97 of 100 — 269 companies hold a clearance here and 10 arrived in the last 12 months (HRX:crowding).",
    "severity": 47,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "7 first-time filers in the last 12 months, including Spinal Simplicity, LLC and Allevion Medical, LLC",
        "recordIds": [
          "K253523",
          "K252546",
          "K253217",
          "K252666",
          "K252458"
        ],
        "severity": 47
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 20% slower — a median 107 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "HRX:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 97 of 100 — 269 companies hold a clearance here and 10 arrived in the last 12 months",
        "recordIds": [
          "HRX:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AHRX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHRX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHRX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHRX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHRX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHRX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHRX"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.710Z"
}