{ "code": "MQV", "deviceName": "Filler, Bone Void, Calcium Compound", "deviceClass": "II", "regulationNumber": "888.3045", "panel": "Orthopedic", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 492, "last12Months": 7 }, "adverseEvents": { "total": 213, "last12Months": 41 }, "reviewDays": { "median": 112, "sampleSize": 492 }, "recalls": { "total": 120, "recent": [ { "resNumber": "Z-2820-2026", "status": "Open, Classified", "recallClass": null, "firm": "IsoTis OrthoBiologics, Inc.", "firmAsPublished": "IsoTis OrthoBiologics, Inc.", "reason": "Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.", "initiated": "2026-07-02" }, { "resNumber": "Z-2131-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Orthorebirth Co Ltd", "firmAsPublished": "Orthorebirth Co Ltd", "reason": "Resorbable bone void filler falls outside standard specifications.", "initiated": "2026-03-25" }, { "resNumber": "Z-2132-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Orthorebirth Co Ltd", "firmAsPublished": "Orthorebirth Co Ltd", "reason": "Resorbable bone void filler falls outside standard specifications.", "initiated": "2026-03-25" }, { "resNumber": "Z-1897-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Xtant Medical Holdings, Inc.", "firmAsPublished": "XTANT Medical Holdings, Inc", "reason": "Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.", "initiated": "2026-03-09" }, { "resNumber": "Z-0540-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Berkeley Advanced Biomaterials, LLC", "firmAsPublished": "Berkeley Advanced Biomaterials, LLC", "reason": "Due to incorrect product label (Incorrect product name identified on outer packaging).", "initiated": "2025-09-02" } ] }, "recentClearances": [ { "kNumber": "K260364", "deviceName": "Device 300419 Strip", "applicant": "Geistlich Pharma AG", "company": "Geistlich Pharma AG", "decisionDate": "2026-06-02", "dateReceived": "2026-02-04" }, { "kNumber": "K252797", "deviceName": "JAZBI™ Resorbable Bone Void Filler", "applicant": "Sdip Innovations Pty, Ltd.", "company": "Sdip Innovations Pty, Ltd.", "decisionDate": "2026-05-26", "dateReceived": "2025-09-03" }, { "kNumber": "K261008", "deviceName": "Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute", "applicant": "Stryker Spine", "company": "Stryker Spine", "decisionDate": "2026-04-24", "dateReceived": "2026-03-26" }, { "kNumber": "K253524", "deviceName": "Adaptos®Fuse Bone Graft", "applicant": "Biomendex OY", "company": "Biomendex OY", "decisionDate": "2026-02-17", "dateReceived": "2025-11-13" }, { "kNumber": "K253147", "deviceName": "FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute", "applicant": "Prosidyan, Inc.", "company": "Prosidyan, Inc.", "decisionDate": "2025-10-22", "dateReceived": "2025-09-25" }, { "kNumber": "K251522", "deviceName": "Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™", "applicant": "Bone Solutions, Inc.", "company": "Bone Solutions, Inc.", "decisionDate": "2025-10-13", "dateReceived": "2025-05-16" }, { "kNumber": "K252085", "deviceName": "Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)", "applicant": "Wright Medical Technology, Inc. (Stryker Corporation)", "company": "Wright Medical Technology, Inc. (Stryker Corporation)", "decisionDate": "2025-09-30", "dateReceived": "2025-07-02" }, { "kNumber": "K251556", "deviceName": "Device 300423 Granules", "applicant": "Geistlich Pharma AG", "company": "Geistlich Pharma AG", "decisionDate": "2025-07-17", "dateReceived": "2025-05-21" }, { "kNumber": "K251720", "deviceName": "OsteoFlo HydroFiber", "applicant": "SurGenTec, LLC", "company": "SurGenTec, LLC", "decisionDate": "2025-07-02", "dateReceived": "2025-06-04" }, { "kNumber": "K251193", "deviceName": "Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft", "applicant": "Medtronic Sofamor Danek, Inc.", "company": "Medtronic Sofamor Danek, Inc.", "decisionDate": "2025-06-12", "dateReceived": "2025-04-17" } ], "topApplicants": [ { "name": "Wrightmedicaltechnologyinc", "count": 28 }, { "name": "Novabone Products, LLC", "count": 19 }, { "name": "Berkeley Advanced Biomaterials, Inc.", "count": 13 }, { "name": "Biocomposites, Ltd.", "count": 11 }, { "name": "Etex Corp.", "count": 11 } ], "topCompanies": [ { "name": "Wrightmedicaltechnologyinc", "count": 28, "spellings": 1 }, { "name": "Novabone Products, LLC", "count": 19, "spellings": 1 }, { "name": "Berkeley Advanced Biomaterials, LLC", "count": 14, "spellings": 2 }, { "name": "Etex Corporation", "count": 14, "spellings": 2 }, { "name": "Orthovita, Inc., dBA Stryker Orthobiologics.", "count": 12, "spellings": 2 } ], "newEntrants": [ { "name": "Sdip Innovations Pty, Ltd.", "since": "2026-05-26", "kNumber": "K252797" }, { "name": "Biomendex OY", "since": "2026-02-17", "kNumber": "K253524" }, { "name": "Wright Medical Technology, Inc. (Stryker Corporation)", "since": "2025-09-30", "kNumber": "K252085" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 2, "expectedLow": 0, "expectedHigh": 10.183226114976177, "isSufficient": true }, { "month": "2025-03-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-07-01", "observed": 17, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 13, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-03-01", "observed": 4, "expectedLow": 0, "expectedHigh": 18.060257662990008, "isSufficient": true } ], "sufficientMonths": 2, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "MQV (Filler, Bone Void, Calcium Compound) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2820-2026, Z-2131-2026, Z-2132-2026, Z-1897-2026, Z-0540-2026). 3 first-time filers in the last 12 months, including Sdip Innovations Pty, Ltd. and Biomendex OY (K252797, K253524, K252085). The code is crowded, scoring 87 of 100 — 164 companies hold a clearance here and 7 arrived in the last 12 months (MQV:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2820-2026", "Z-2131-2026", "Z-2132-2026", "Z-1897-2026", "Z-0540-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "3 first-time filers in the last 12 months, including Sdip Innovations Pty, Ltd. and Biomendex OY", "recordIds": [ "K252797", "K253524", "K252085" ], "severity": 43 }, { "kind": "crowding", "detail": "the code is crowded, scoring 87 of 100 — 164 companies hold a clearance here and 7 arrived in the last 12 months", "recordIds": [ "MQV: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%3AMQV" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQV" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQV" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMQV" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMQV" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMQV" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMQV" } ], "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" }