{ "code": "NKB", "deviceName": "Thoracolumbosacral Pedicle Screw System", "deviceClass": "II", "regulationNumber": "888.3070", "panel": "Orthopedic", "definition": "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 905, "last12Months": 31 }, "adverseEvents": { "total": 3730, "last12Months": 816 }, "reviewDays": { "median": 76, "sampleSize": 905 }, "recalls": { "total": 181, "recent": [ { "resNumber": "Z-2762-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "SEASPINE ORTHOPEDICS CORPORATION", "firmAsPublished": "SEASPINE ORTHOPEDICS CORPORATION", "reason": "Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.", "initiated": "2026-05-28" }, { "resNumber": "Z-2859-2026", "status": "Open, Classified", "recallClass": null, "firm": "Innovasis, Inc", "firmAsPublished": "Innovasis, Inc", "reason": "Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.", "initiated": "2026-05-22" }, { "resNumber": "Z-0478-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Orthofix U.S. LLC", "firmAsPublished": "Orthofix U.S. LLC", "reason": "Polyaxial screws do not meet performance standards.", "initiated": "2025-09-19" }, { "resNumber": "Z-2279-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "SPINEART SA", "firmAsPublished": "SPINEART SA", "reason": "Cannulated fenestrated polyaxial screws may be incorrectly labeled", "initiated": "2025-06-30" }, { "resNumber": "Z-2280-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "SPINEART SA", "firmAsPublished": "SPINEART SA", "reason": "Cannulated fenestrated polyaxial screws may be incorrectly labeled", "initiated": "2025-06-30" } ] }, "recentClearances": [ { "kNumber": "K260362", "deviceName": "QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)", "applicant": "MANTIZ Co., Ltd.", "company": "MANTIZ Co., Ltd.", "decisionDate": "2026-07-24", "dateReceived": "2026-02-04" }, { "kNumber": "K253943", "deviceName": "Tiger 2 System", "applicant": "Zavation Medical Products, LLC", "company": "Zavation Medical Products, LLC", "decisionDate": "2026-07-24", "dateReceived": "2025-12-10" }, { "kNumber": "K261284", "deviceName": "Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System", "applicant": "Alphatec Spine, Inc.", "company": "Alphatec Spine, Inc.", "decisionDate": "2026-07-14", "dateReceived": "2026-04-17" }, { "kNumber": "K253802", "deviceName": "KHEIRON® Spinal Fixation System, including patient specific K-ROD", "applicant": "S.M.A.I.O", "company": "S.M.A.I.O", "decisionDate": "2026-07-01", "dateReceived": "2025-11-28" }, { "kNumber": "K253045", "deviceName": "“Socko” Vimax Spinal Fixation System", "applicant": "Socko Medical Co., Ltd.", "company": "Socko Medical Co., Ltd.", "decisionDate": "2026-06-17", "dateReceived": "2025-09-22" }, { "kNumber": "K251251", "deviceName": "ChanPin Pedicle Screw Spinal System", "applicant": "Chanpin Medtak Co., Ltd.", "company": "Chanpin Medtak Co., Ltd.", "decisionDate": "2026-06-09", "dateReceived": "2025-04-23" }, { "kNumber": "K260989", "deviceName": "Varion Thoracolumbar Fixation System", "applicant": "Kyocera Medical Technologies Inc. (KMTI)", "company": "Kyocera Medical Technologies Inc. (KMTI)", "decisionDate": "2026-05-15", "dateReceived": "2026-03-25" }, { "kNumber": "K253739", "deviceName": "SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System", "applicant": "Globus Medical, Inc.", "company": "Globus Medical, Inc.", "decisionDate": "2026-05-07", "dateReceived": "2025-11-24" }, { "kNumber": "K261130", "deviceName": "AccelFix Spinal Fixation System", "applicant": "L&K BIOMED Co., Ltd.", "company": "L and K Biomed Corporation Limited", "decisionDate": "2026-05-05", "dateReceived": "2026-04-06" }, { "kNumber": "K253966", "deviceName": "PERLA® TL Posterior Thoraco-lumbar Fixation System", "applicant": "Spineart SA", "company": "SPINEART SA", "decisionDate": "2026-05-01", "dateReceived": "2025-12-11" } ], "topApplicants": [ { "name": "Medtronic Sofamor Danek USA, Inc.", "count": 46 }, { "name": "Medtronic Sofamor Danek", "count": 36 }, { "name": "Depuy Spine, Inc.", "count": 30 }, { "name": "Globus Medical, Inc.", "count": 24 }, { "name": "Stryker Spine", "count": 22 } ], "topCompanies": [ { "name": "Medtronic Sofamor Danek, Inc.", "count": 50, "spellings": 2 }, { "name": "Medtronic Sofamor Danek USA, Inc", "count": 48, "spellings": 2 }, { "name": "DePuy Spine, Inc.", "count": 30, "spellings": 1 }, { "name": "Globus Medical, Inc.", "count": 24, "spellings": 1 }, { "name": "Life Spine, Inc.", "count": 22, "spellings": 3 } ], "newEntrants": [ { "name": "MANTIZ Co., Ltd.", "since": "2026-07-24", "kNumber": "K260362" }, { "name": "Socko Medical Co., Ltd.", "since": "2026-06-17", "kNumber": "K253045" }, { "name": "Chanpin Medtak Co., Ltd.", "since": "2026-06-09", "kNumber": "K251251" }, { "name": "Kyocera Medical Technologies Inc. (KMTI)", "since": "2026-05-15", "kNumber": "K260989" }, { "name": "ZheJiang Decans Medical Devices Co., Ltd.", "since": "2026-04-29", "kNumber": "K252542" }, { "name": "Osteomni, Inc.", "since": "2026-02-24", "kNumber": "K254247" }, { "name": "Box Spine, LLC", "since": "2026-02-23", "kNumber": "K253169" }, { "name": "Highridge Medical, LLC", "since": "2025-12-17", "kNumber": "K253093" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 43, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 53, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 96, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 67, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 47, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 79, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 55, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 73, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 126, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 360, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 64, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 92, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 109, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 153, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 93, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 105, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 127, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 173, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 97, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 114, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 119, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 84, "expectedLow": 0, "expectedHigh": 261.8325308471141, "isSufficient": true }, { "month": "2025-02-01", "observed": 100, "expectedLow": 41.39887912473102, "expectedHigh": 133.57090557278525, "isSufficient": true }, { "month": "2025-03-01", "observed": 95, "expectedLow": 57.47885452020945, "expectedHigh": 147.5228893696513, "isSufficient": true }, { "month": "2025-04-01", "observed": 101, "expectedLow": 57.79031343775204, "expectedHigh": 149.93868428456054, "isSufficient": true }, { "month": "2025-05-01", "observed": 122, "expectedLow": 53.572809254816846, "expectedHigh": 140.47919015884477, "isSufficient": true }, { "month": "2025-06-01", "observed": 76, "expectedLow": 65.9931604316188, "expectedHigh": 149.48070470189006, "isSufficient": true }, { "month": "2025-07-01", "observed": 53, "expectedLow": 83.90320651390996, "expectedHigh": 224.71055389168882, "isSufficient": true }, { "month": "2025-08-01", "observed": 63, "expectedLow": 22.657717257986985, "expectedHigh": 165.30352794428381, "isSufficient": true }, { "month": "2025-09-01", "observed": 99, "expectedLow": 8.861325053851797, "expectedHigh": 171.00089193415565, "isSufficient": true }, { "month": "2025-10-01", "observed": 103, "expectedLow": 27.227153438014145, "expectedHigh": 154.26877566985956, "isSufficient": true }, { "month": "2025-11-01", "observed": 133, "expectedLow": 28.22317143930314, "expectedHigh": 142.6316618104839, "isSufficient": true }, { "month": "2025-12-01", "observed": 114, "expectedLow": 44.01406946542116, "expectedHigh": 176.98098791457818, "isSufficient": true }, { "month": "2026-01-01", "observed": 96, "expectedLow": 52.76452218740609, "expectedHigh": 203.77817355013286, "isSufficient": true }, { "month": "2026-02-01", "observed": 121, "expectedLow": 35.41670201934942, "expectedHigh": 166.2308106272987, "isSufficient": true }, { "month": "2026-03-01", "observed": 99, "expectedLow": 47.47746297036487, "expectedHigh": 186.23701804101768, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "NKB (Thoracolumbosacral Pedicle Screw System) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2762-2026, Z-2859-2026, Z-0478-2026). 11 first-time filers in the last 12 months, including MANTIZ Co., Ltd. and Socko Medical Co., Ltd (K260362, K253045, K251251, K260989, K252542). The code is crowded, scoring 100 of 100 — 240 companies hold a clearance here and 31 arrived in the last 12 months (NKB:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2762-2026", "Z-2859-2026", "Z-0478-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "11 first-time filers in the last 12 months, including MANTIZ Co., Ltd. and Socko Medical Co., Ltd.", "recordIds": [ "K260362", "K253045", "K251251", "K260989", "K252542" ], "severity": 50 }, { "kind": "crowding", "detail": "the code is crowded, scoring 100 of 100 — 240 companies hold a clearance here and 31 arrived in the last 12 months", "recordIds": [ "NKB: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%3ANKB" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANKB" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANKB" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ANKB" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ANKB" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ANKB" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ANKB" } ], "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": "2026-08-11T13:51:45.748Z" }