{ "code": "MQP", "deviceName": "Spinal Vertebral Body Replacement Device", "deviceClass": "II", "regulationNumber": "888.3060", "panel": "Orthopedic", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 278, "last12Months": 2 }, "adverseEvents": { "total": 362, "last12Months": 108 }, "reviewDays": { "median": 88, "sampleSize": 278 }, "recalls": { "total": 46, "recent": [ { "resNumber": "Z-0738-2023", "status": "Open, Classified", "recallClass": "Class II", "firm": "NuVasive Inc", "firmAsPublished": "NuVasive Inc", "reason": "Potential that insert will be unable to disengage from the vertebral body replacement device/implant", "initiated": "2022-11-10" }, { "resNumber": "Z-0403-2021", "status": "Terminated", "recallClass": "Class III", "firm": "Synthes (USA) Products LLC", "firmAsPublished": "Synthes (USA) Products LLC", "reason": "Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM\ninstead of 'specially controlled medical device\"", "initiated": "2020-09-21" }, { "resNumber": "Z-0404-2021", "status": "Terminated", "recallClass": "Class III", "firm": "Synthes (USA) Products LLC", "firmAsPublished": "Synthes (USA) Products LLC", "reason": "Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM\ninstead of 'specially controlled medical device\"", "initiated": "2020-09-21" }, { "resNumber": "Z-0405-2021", "status": "Terminated", "recallClass": "Class III", "firm": "Synthes (USA) Products LLC", "firmAsPublished": "Synthes (USA) Products LLC", "reason": "Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM\ninstead of 'specially controlled medical device\"", "initiated": "2020-09-21" }, { "resNumber": "Z-0406-2021", "status": "Terminated", "recallClass": "Class III", "firm": "Synthes (USA) Products LLC", "firmAsPublished": "Synthes (USA) Products LLC", "reason": "Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM\ninstead of 'specially controlled medical device\"", "initiated": "2020-09-21" } ] }, "recentClearances": [ { "kNumber": "K261031", "deviceName": "POSEIDON ST", "applicant": "Signus Medinzintechnik GmbH", "company": "Signus Medinzintechnik GmbH", "decisionDate": "2026-07-10", "dateReceived": "2026-03-30" }, { "kNumber": "K253158", "deviceName": "VyBrate™ VBR System", "applicant": "Vy Spine, LLC", "company": "Vy Spine, LLC", "decisionDate": "2026-01-07", "dateReceived": "2025-09-26" }, { "kNumber": "K241468", "deviceName": "Vertiwedge® Intraosseous System", "applicant": "Foundation Surgical Group, Inc.", "company": "Foundation Surgical Group, Inc.", "decisionDate": "2024-11-07", "dateReceived": "2024-05-24" }, { "kNumber": "K232790", "deviceName": "KONG®-TL VBR System and KONG® C VBR System", "applicant": "Icotec AG", "company": "Icotec Ag", "decisionDate": "2024-04-04", "dateReceived": "2023-09-11" }, { "kNumber": "K233359", "deviceName": "DOMINION Expandable Corpectomy System", "applicant": "Astura Medical", "company": "Astura Medical", "decisionDate": "2024-03-08", "dateReceived": "2023-09-29" }, { "kNumber": "K231134", "deviceName": "VerteLoc Spinal System", "applicant": "Signature Orthopaedics Pty, Ltd.", "company": "Signature Orthopaedics Pty Limited", "decisionDate": "2024-02-13", "dateReceived": "2023-04-21" }, { "kNumber": "K232173", "deviceName": "Ascend VBR System, Ascend NanoTec VBR System", "applicant": "Alphatec Spine, Inc.", "company": "Alphatec Spine, Inc.", "decisionDate": "2023-10-06", "dateReceived": "2023-07-21" }, { "kNumber": "K211892", "deviceName": "ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)", "applicant": "Arftx Medical, LLC", "company": "Arftx Medical, LLC", "decisionDate": "2022-10-06", "dateReceived": "2021-06-21" }, { "kNumber": "K202637", "deviceName": "F3D Corpectomy System", "applicant": "Corelink, LLC", "company": "CoreLink LLC", "decisionDate": "2020-12-23", "dateReceived": "2020-09-11" }, { "kNumber": "K200235", "deviceName": "KONG-TL VBR System, KONG-C VBR System", "applicant": "Icotec AG", "company": "Icotec Ag", "decisionDate": "2020-05-29", "dateReceived": "2020-01-30" } ], "topApplicants": [ { "name": "Medtronic Sofamor Danek", "count": 24 }, { "name": "Globus Medical, Inc.", "count": 11 }, { "name": "Interpore Cross Intl.", "count": 10 }, { "name": "Spine Wave, Inc.", "count": 10 }, { "name": "Depuyacromed", "count": 8 } ], "topCompanies": [ { "name": "Medtronic Sofamor Danek, Inc.", "count": 30, "spellings": 2 }, { "name": "Globus Medical, Inc.", "count": 11, "spellings": 1 }, { "name": "Interpore Cross Intl.", "count": 10, "spellings": 1 }, { "name": "Spine Wave, Inc.", "count": 10, "spellings": 1 }, { "name": "Depuyacromed", "count": 8, "spellings": 1 } ], "newEntrants": [ { "name": "Signus Medinzintechnik GmbH", "since": "2026-07-10", "kNumber": "K261031" }, { "name": "Vy Spine, LLC", "since": "2026-01-07", "kNumber": "K253158" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 23, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 22, "expectedLow": 0, "expectedHigh": 18.10402071528008, "isSufficient": true }, { "month": "2025-02-01", "observed": 8, "expectedLow": 0, "expectedHigh": 21.789873651201546, "isSufficient": true }, { "month": "2025-03-01", "observed": 23, "expectedLow": 0, "expectedHigh": 23.78180747821461, "isSufficient": true }, { "month": "2025-04-01", "observed": 5, "expectedLow": 1.5345642064378753, "expectedHigh": 28.186843138882725, "isSufficient": true }, { "month": "2025-05-01", "observed": 21, "expectedLow": 0, "expectedHigh": 23.789034582347146, "isSufficient": true }, { "month": "2025-06-01", "observed": 14, "expectedLow": 0.27298531272596477, "expectedHigh": 29.003810657167428, "isSufficient": true }, { "month": "2025-07-01", "observed": 7, "expectedLow": 0.4117790384028611, "expectedHigh": 45.049900102579244, "isSufficient": true }, { "month": "2025-08-01", "observed": 8, "expectedLow": 0, "expectedHigh": 30.91245758107539, "isSufficient": true }, { "month": "2025-09-01", "observed": 16, "expectedLow": 0, "expectedHigh": 30.876380822137374, "isSufficient": true }, { "month": "2025-10-01", "observed": 11, "expectedLow": 0, "expectedHigh": 31.05808693976863, "isSufficient": true }, { "month": "2025-11-01", "observed": 14, "expectedLow": 0, "expectedHigh": 26.793986139241365, "isSufficient": true }, { "month": "2025-12-01", "observed": 10, "expectedLow": 0, "expectedHigh": 29.842663570429732, "isSufficient": true }, { "month": "2026-01-01", "observed": 8, "expectedLow": 0, "expectedHigh": 33.69200067392348, "isSufficient": true }, { "month": "2026-02-01", "observed": 10, "expectedLow": 0, "expectedHigh": 25.53550637503626, "isSufficient": true }, { "month": "2026-03-01", "observed": 32, "expectedLow": 0, "expectedHigh": 28.147871345047076, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "MQP (Spinal Vertebral Body Replacement Device) has three findings, most consequential first. Adverse events reported in 2026-03 ran high — 32 reports against an expected 0 to 28 (MQP:MAUDE:2026-03). 2 first-time filers in the last 12 months, Signus Medinzintechnik GmbH and Vy Spine, LLC (K261031, K253158). The code is crowded, scoring 71 of 100 — 98 companies hold a clearance here and 2 arrived in the last 12 months (MQP:crowding).", "severity": 60, "factors": [ { "kind": "spike", "detail": "adverse events reported in 2026-03 ran high — 32 reports against an expected 0 to 28", "recordIds": [ "MQP:MAUDE:2026-03" ], "severity": 60 }, { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Signus Medinzintechnik GmbH and Vy Spine, LLC", "recordIds": [ "K261031", "K253158" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 71 of 100 — 98 companies hold a clearance here and 2 arrived in the last 12 months", "recordIds": [ "MQP: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%3AMQP" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQP" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQP" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMQP" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMQP" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMQP" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMQP" } ], "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": "2026-08-11T13:51:45.746Z" }