{ "code": "ODP", "deviceName": "Intervertebral Fusion Device With Bone Graft, Cervical", "deviceClass": "II", "regulationNumber": "888.3080", "panel": "Orthopedic", "definition": "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 352, "last12Months": 24 }, "adverseEvents": { "total": 158, "last12Months": 38 }, "reviewDays": { "median": 117, "sampleSize": 352 }, "recalls": { "total": 11, "recent": [ { "resNumber": "Z-0891-2026", "status": "Open, Classified", "recallClass": "Class III", "firm": "Orthofix U.S. LLC", "firmAsPublished": "Orthofix U.S. LLC", "reason": "Labeling contains claims that are not consistently present.", "initiated": "2025-11-03" }, { "resNumber": "Z-0896-2026", "status": "Open, Classified", "recallClass": "Class III", "firm": "Orthofix U.S. LLC", "firmAsPublished": "Orthofix U.S. LLC", "reason": "Labeling contains claims that are not consistently present.", "initiated": "2025-11-03" }, { "resNumber": "Z-2456-2023", "status": "Open, Classified", "recallClass": "Class II", "firm": "Medicrea International", "firmAsPublished": "Medicrea International", "reason": "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.", "initiated": "2023-07-12" }, { "resNumber": "Z-2460-2023", "status": "Open, Classified", "recallClass": "Class II", "firm": "Medicrea International", "firmAsPublished": "Medicrea International", "reason": "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.", "initiated": "2023-07-12" }, { "resNumber": "Z-2462-2023", "status": "Open, Classified", "recallClass": "Class II", "firm": "Medicrea International", "firmAsPublished": "Medicrea International", "reason": "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.", "initiated": "2023-07-12" } ] }, "recentClearances": [ { "kNumber": "K253041", "deviceName": "3d Cage Cervical", "applicant": "Fims Co., Ltd.", "company": "Fims Co., Ltd.", "decisionDate": "2026-07-23", "dateReceived": "2025-09-22" }, { "kNumber": "K262061", "deviceName": "Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM", "applicant": "Stryker Spine", "company": "Stryker Spine", "decisionDate": "2026-07-17", "dateReceived": "2026-06-18" }, { "kNumber": "K254130", "deviceName": "C.A. Medical Interbody Fusion System", "applicant": "C.A. Medical, LLC", "company": "C.A. Medical, LLC", "decisionDate": "2026-07-08", "dateReceived": "2025-12-22" }, { "kNumber": "K260840", "deviceName": "BluEX Cervical Expandable Cage System", "applicant": "L&K BIOMED Co., Ltd.", "company": "L and K Biomed Corporation Limited", "decisionDate": "2026-05-16", "dateReceived": "2026-03-16" }, { "kNumber": "K260850", "deviceName": "OSTEOMNI SPINAL CAGES SYSTEM", "applicant": "Osteomni, Inc.", "company": "Osteomni, Inc.", "decisionDate": "2026-05-12", "dateReceived": "2026-03-16" }, { "kNumber": "K260549", "deviceName": "ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System", "applicant": "Zsfab, Inc.", "company": "Zsfab, Inc.", "decisionDate": "2026-04-24", "dateReceived": "2026-02-18" }, { "kNumber": "K253260", "deviceName": "ORIO-3D Cage System", "applicant": "SpineCraft", "company": "Spinecraft, Inc.", "decisionDate": "2026-04-16", "dateReceived": "2025-09-29" }, { "kNumber": "K260340", "deviceName": "HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES", "applicant": "HC Biologics, LLC", "company": "HC Biologics, LLC", "decisionDate": "2026-04-13", "dateReceived": "2026-02-02" }, { "kNumber": "K242303", "deviceName": "MOD-C", "applicant": "Orthomod, LLC", "company": "Orthomod, LLC", "decisionDate": "2026-04-01", "dateReceived": "2024-08-05" }, { "kNumber": "K252240", "deviceName": "Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System", "applicant": "Spectrum Spine", "company": "Spectrum Spine, Inc.", "decisionDate": "2026-03-30", "dateReceived": "2025-07-17" } ], "topApplicants": [ { "name": "Orthofix, Inc.", "count": 9 }, { "name": "Nu Vasive, Incorporated", "count": 8 }, { "name": "Gbs Commonwealth Co., Ltd.", "count": 7 }, { "name": "Globus Medical, Inc.", "count": 7 }, { "name": "Medtronic Sofamor Danek USA, Inc.", "count": 7 } ], "topCompanies": [ { "name": "Orthofix, Inc.", "count": 10, "spellings": 2 }, { "name": "Medtronic Sofamor Danek USA, Inc", "count": 8, "spellings": 2 }, { "name": "Nu Vasive, Incorporated", "count": 8, "spellings": 1 }, { "name": "Gbs Commonwealth Co., Ltd.", "count": 7, "spellings": 1 }, { "name": "Globus Medical, Inc.", "count": 7, "spellings": 1 } ], "newEntrants": [ { "name": "Fims Co., Ltd.", "since": "2026-07-23", "kNumber": "K253041" }, { "name": "C.A. Medical, LLC", "since": "2026-07-08", "kNumber": "K254130" }, { "name": "Osteomni, Inc.", "since": "2026-05-12", "kNumber": "K260850" }, { "name": "HC Biologics, LLC", "since": "2026-04-13", "kNumber": "K260340" }, { "name": "Orthomod, LLC", "since": "2026-04-01", "kNumber": "K242303" }, { "name": "Spinepoint, LLC", "since": "2026-03-25", "kNumber": "K252432" }, { "name": "NanoHive Medical, LLC", "since": "2026-02-13", "kNumber": "K254105" }, { "name": "Sync Surgical", "since": "2026-01-14", "kNumber": "K252219" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 4, "expectedLow": 0.37666507136577426, "expectedHigh": 11.777765475242807, "isSufficient": true }, { "month": "2025-02-01", "observed": 8, "expectedLow": 0.1602846373099781, "expectedHigh": 9.435994838948217, "isSufficient": true }, { "month": "2025-03-01", "observed": 8, "expectedLow": 0.6040351703815482, "expectedHigh": 12.259950546828678, "isSufficient": true }, { "month": "2025-04-01", "observed": 3, "expectedLow": 0.8189755231498437, "expectedHigh": 13.421126128381148, "isSufficient": true }, { "month": "2025-05-01", "observed": 3, "expectedLow": 0, "expectedHigh": 11.422776286855202, "isSufficient": true }, { "month": "2025-06-01", "observed": 3, "expectedLow": 0, "expectedHigh": 10.87732201626595, "isSufficient": true }, { "month": "2025-07-01", "observed": 1, "expectedLow": 0, "expectedHigh": 16.232524604129484, "isSufficient": true }, { "month": "2025-08-01", "observed": 5, "expectedLow": 0, "expectedHigh": 11.584274341534297, "isSufficient": true }, { "month": "2025-10-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 8, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "ODP (Intervertebral Fusion Device With Bone Graft, Cervical) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class III) (Z-0891-2026, Z-0896-2026). 12 first-time filers in the last 12 months, including Fims Co., Ltd. and C.A. Medical, LLC (K253041, K254130, K260850, K260340, K242303). The code is crowded, scoring 99 of 100 — 184 companies hold a clearance here and 24 arrived in the last 12 months (ODP:crowding).", "severity": 70, "factors": [ { "kind": "recall", "detail": "2 recalls opened in the last 12 months and not yet terminated (Class III)", "recordIds": [ "Z-0891-2026", "Z-0896-2026" ], "severity": 70 }, { "kind": "new_entrant", "detail": "12 first-time filers in the last 12 months, including Fims Co., Ltd. and C.A. Medical, LLC", "recordIds": [ "K253041", "K254130", "K260850", "K260340", "K242303" ], "severity": 50 }, { "kind": "crowding", "detail": "the code is crowded, scoring 99 of 100 — 184 companies hold a clearance here and 24 arrived in the last 12 months", "recordIds": [ "ODP: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%3AODP" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AODP" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AODP" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AODP" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AODP" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AODP" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AODP" } ], "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": "2026-08-11T13:51:45.749Z" }