{
  "code": "LPH",
  "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",
  "deviceClass": "II",
  "regulationNumber": "888.3358",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 562,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 16921,
    "last12Months": 3872
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 562
  },
  "recalls": {
    "total": 297,
    "recent": [
      {
        "resNumber": "Z-1234-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Encore Medical, Lp",
        "firmAsPublished": "Encore Medical, LP",
        "reason": "942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a  packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.",
        "initiated": "2026-01-05"
      },
      {
        "resNumber": "Z-0418-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.",
        "initiated": "2025-09-26"
      },
      {
        "resNumber": "Z-0419-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.",
        "initiated": "2025-09-26"
      },
      {
        "resNumber": "Z-0148-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Biopro, Inc.",
        "firmAsPublished": "BioPro, Inc.",
        "reason": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
        "initiated": "2025-09-09"
      },
      {
        "resNumber": "Z-0149-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Biopro, Inc.",
        "firmAsPublished": "BioPro, Inc.",
        "reason": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
        "initiated": "2025-09-09"
      }
    ]
  },
  "recentClearances": [
    {
      "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",
      "applicant": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics",
      "company": "Howmedica Osteonics Corp.",
      "decisionDate": "2026-07-10",
      "dateReceived": "2026-05-15"
    },
    {
      "kNumber": "K243192",
      "deviceName": "iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating",
      "applicant": "Nextstep Arthopedix, LLC",
      "company": "Nextstep Arthopedix, LLC",
      "decisionDate": "2026-06-05",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K251270",
      "deviceName": "Taperloc® Complete Hip Stem",
      "applicant": "Biomet, Inc.",
      "company": "Biomet, Inc.",
      "decisionDate": "2026-05-19",
      "dateReceived": "2025-04-24"
    },
    {
      "kNumber": "K252623",
      "deviceName": "G7® Revision Acetabular System",
      "applicant": "Zimmer, Inc.",
      "company": "Zimmer, Inc.",
      "decisionDate": "2026-02-04",
      "dateReceived": "2025-08-19"
    },
    {
      "kNumber": "K251043",
      "deviceName": "Mpact 3D Metal Implants Extension – DMLS Technology",
      "applicant": "Medacta International S.A.",
      "company": "Medacta International S.A.",
      "decisionDate": "2026-01-28",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K252067",
      "deviceName": "Velora Acetabular System",
      "applicant": "Restor3D, Inc.",
      "company": "restor3d Inc.",
      "decisionDate": "2025-12-05",
      "dateReceived": "2025-07-01"
    },
    {
      "kNumber": "K252846",
      "deviceName": "TaperSet™ Hip System",
      "applicant": "Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics",
      "company": "Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics",
      "decisionDate": "2025-11-20",
      "dateReceived": "2025-09-08"
    },
    {
      "kNumber": "K251833",
      "deviceName": "EMPOWR Acetabular® Liner Extension",
      "applicant": "Encore Medical L.P.",
      "company": "Encore Medical, L.P. Dba Djo Surgical",
      "decisionDate": "2025-11-12",
      "dateReceived": "2025-06-16"
    },
    {
      "kNumber": "K251718",
      "deviceName": "ArTT Augments and Buttresses and Bone Screws",
      "applicant": "Lima Corporate S.P.A.",
      "company": "Lima Corporate S.P.A.",
      "decisionDate": "2025-08-29",
      "dateReceived": "2025-06-04"
    },
    {
      "kNumber": "K250989",
      "deviceName": "Stryker and Serf hip devices",
      "applicant": "Howmedica Osteonics Corp (Dba Stryker Orthopaedics)",
      "company": "Howmedica Osteonics Corp.",
      "decisionDate": "2025-07-25",
      "dateReceived": "2025-03-31"
    }
  ],
  "topApplicants": [
    {
      "name": "Zimmer, Inc.",
      "count": 45
    },
    {
      "name": "Biomet, Inc.",
      "count": 44
    },
    {
      "name": "DePuy Orthopaedics, Inc.",
      "count": 32
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 32
    },
    {
      "name": "Depuy, Inc.",
      "count": 24
    }
  ],
  "topCompanies": [
    {
      "name": "Zimmer, Inc.",
      "count": 46,
      "spellings": 2
    },
    {
      "name": "Biomet, Inc.",
      "count": 44,
      "spellings": 1
    },
    {
      "name": "DePuy Orthopaedics, Inc.",
      "count": 33,
      "spellings": 2
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 32,
      "spellings": 1
    },
    {
      "name": "Depuy, Inc.",
      "count": 24,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Nextstep Arthopedix, LLC",
      "since": "2026-06-05",
      "kNumber": "K243192"
    },
    {
      "name": "restor3d Inc.",
      "since": "2025-12-05",
      "kNumber": "K252067"
    },
    {
      "name": "Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics",
      "since": "2025-11-20",
      "kNumber": "K252846"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 415,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 394,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 509,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 385,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 444,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 473,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 420,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 444,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 364,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 406,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 449,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 498,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 476,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 546,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 518,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 484,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 362,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 455,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 566,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 386,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 482,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 404,
        "expectedLow": 288.8083329729082,
        "expectedHigh": 555.084711528636,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 327,
        "expectedLow": 248.72050278492028,
        "expectedHigh": 478.12242209884306,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 342,
        "expectedLow": 261.05440887077845,
        "expectedHigh": 529.4819162292334,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 537,
        "expectedLow": 250.95063509430636,
        "expectedHigh": 532.5441683199966,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 462,
        "expectedLow": 267.5278384695269,
        "expectedHigh": 549.7026090049924,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 586,
        "expectedLow": 298.3571698976672,
        "expectedHigh": 582.9867337482016,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 639,
        "expectedLow": 508.251037617966,
        "expectedHigh": 1009.489550703774,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 528,
        "expectedLow": 354.9489797828944,
        "expectedHigh": 734.4077521667839,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 574,
        "expectedLow": 389.08194706369324,
        "expectedHigh": 750.1616004101963,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 546,
        "expectedLow": 388.842362429373,
        "expectedHigh": 747.7746194026333,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 546,
        "expectedLow": 344.830221710752,
        "expectedHigh": 663.4715130792342,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 572,
        "expectedLow": 407.0115987509423,
        "expectedHigh": 740.6498734663745,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 472,
        "expectedLow": 469.40151839158193,
        "expectedHigh": 852.4719627187889,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 376,
        "expectedLow": 331.3738184425859,
        "expectedHigh": 689.995928158903,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 375,
        "expectedLow": 300.3064084340384,
        "expectedHigh": 729.9489988656269,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1234-2026, Z-0418-2026, Z-0419-2026, Z-0148-2026, Z-0149-2026). 3 first-time filers in the last 12 months, including Nextstep Arthopedix, LLC and restor3d Inc (K243192, K252067, K252846). The code is crowded, scoring 84 of 100 — 107 companies hold a clearance here and 9 arrived in the last 12 months (LPH:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1234-2026",
          "Z-0418-2026",
          "Z-0419-2026",
          "Z-0148-2026",
          "Z-0149-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Nextstep Arthopedix, LLC and restor3d Inc.",
        "recordIds": [
          "K243192",
          "K252067",
          "K252846"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 84 of 100 — 107 companies hold a clearance here and 9 arrived in the last 12 months",
        "recordIds": [
          "LPH: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%3ALPH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALPH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALPH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALPH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALPH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALPH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALPH"
    }
  ],
  "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": "2026-08-11T13:51:45.740Z"
}