{ "code": "JEY", "deviceName": "Plate, Bone", "deviceClass": "II", "regulationNumber": "872.4760", "panel": "Dental", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 293, "last12Months": 4 }, "adverseEvents": { "total": 2206, "last12Months": 619 }, "reviewDays": { "median": 90, "sampleSize": 293 }, "recalls": { "total": 111, "recent": [ { "resNumber": "Z-2287-2023", "status": "Completed", "recallClass": "Class II", "firm": "Materialise N.V.", "firmAsPublished": "Materialise N.V.", "reason": "Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request", "initiated": "2023-06-19" }, { "resNumber": "Z-0629-2021", "status": "Terminated", "recallClass": "Class II", "firm": "Biomet, Inc.", "firmAsPublished": "Biomet, Inc.", "reason": "Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.", "initiated": "2020-11-25" }, { "resNumber": "Z-2698-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Synthes, Inc.", "firmAsPublished": "Synthes, Inc.", "reason": "One lot of MatrixNEURO 5mm screws was packaged in a body clip etched \"4\", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.", "initiated": "2020-06-18" }, { "resNumber": "Z-2739-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Synthes Produktions GmbH", "firmAsPublished": "Synthes Produktions GmbH", "reason": "One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).", "initiated": "2020-06-16" }, { "resNumber": "Z-1484-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Materialise N.V.", "firmAsPublished": "Materialise N.V.", "reason": "Custom surgical kits contain a plate different than indicated by the package labeling.", "initiated": "2020-02-03" } ] }, "recentClearances": [ { "kNumber": "K253206", "deviceName": "METICULY Patient-specific CMF solution", "applicant": "Meticuly Co., Ltd.", "company": "Meticuly Co., Ltd.", "decisionDate": "2026-07-25", "dateReceived": "2025-09-26" }, { "kNumber": "K252246", "deviceName": "Leforte MMF System", "applicant": "Jeil Medical Corporation", "company": "Jeil Medical Corporation", "decisionDate": "2026-04-02", "dateReceived": "2025-07-18" }, { "kNumber": "K253373", "deviceName": "Southern Craniomaxillofacial (CMF) System", "applicant": "Southern Medical (Pty) , Ltd.", "company": "Southern Medical (Pty) , Ltd.", "decisionDate": "2025-12-19", "dateReceived": "2025-09-30" }, { "kNumber": "K251441", "deviceName": "Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System", "applicant": "Inion OY", "company": "Inion Ltd.", "decisionDate": "2025-11-07", "dateReceived": "2025-05-09" }, { "kNumber": "K241314", "deviceName": "KLS Martin Oral-Max Implants MR Conditional (bundled)", "applicant": "KLS-Martin L.P.", "company": "KLS-Martin L.P.", "decisionDate": "2024-08-16", "dateReceived": "2024-05-10" }, { "kNumber": "K240651", "deviceName": "MRI Universal", "applicant": "Stryker Leibinger GmbH & Co KG", "company": "Stryker Leibinger GmbH & Co. KG", "decisionDate": "2024-07-12", "dateReceived": "2024-03-07" }, { "kNumber": "K233874", "deviceName": "tmCMF Solution", "applicant": "Techmah Cmf", "company": "Techmah Cmf", "decisionDate": "2024-07-11", "dateReceived": "2023-12-07" }, { "kNumber": "K232889", "deviceName": "METICULY Patient-specific titanium maxillofacial mesh implant", "applicant": "Meticuly Co., Ltd.", "company": "Meticuly Co., Ltd.", "decisionDate": "2024-04-30", "dateReceived": "2023-09-18" }, { "kNumber": "K232350", "deviceName": "Stryker Facial iD System", "applicant": "Stryker Craniomaxillofacial", "company": "Stryker Craniomaxillofacial", "decisionDate": "2024-01-13", "dateReceived": "2023-08-07" }, { "kNumber": "K230398", "deviceName": "MedCAD® AccuPlate® 3DTi Patient-Specific Plating System", "applicant": "Medcad", "company": "Medcad", "decisionDate": "2023-09-26", "dateReceived": "2023-02-16" } ], "topApplicants": [ { "name": "Synthes (Usa)", "count": 38 }, { "name": "Bioplate, Inc.", "count": 16 }, { "name": "KLS-Martin L.P.", "count": 15 }, { "name": "Walter Lorenz Surgical, Inc.", "count": 15 }, { "name": "Stryker", "count": 13 } ], "topCompanies": [ { "name": "Synthes USA", "count": 38, "spellings": 1 }, { "name": "KLS-Martin L.P.", "count": 18, "spellings": 2 }, { "name": "Bioplate, Inc.", "count": 16, "spellings": 1 }, { "name": "Walter Lorenz Surgical, Inc.", "count": 15, "spellings": 1 }, { "name": "Stryker Corporation", "count": 13, "spellings": 1 } ], "newEntrants": [ { "name": "Southern Medical (Pty) , Ltd.", "since": "2025-12-19", "kNumber": "K253373" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 23, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 47, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 32, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 15, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 24, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 88, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 35, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 50, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 35, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 23, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 36, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 23, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 57, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 33, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 39, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 103, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 45, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 128, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 62, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 88, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 59, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 44, "expectedLow": 5.902114823526946, "expectedHigh": 123.4770425775951, "isSufficient": true }, { "month": "2025-02-01", "observed": 19, "expectedLow": 2.5172384959265415, "expectedHigh": 99.67665845952614, "isSufficient": true }, { "month": "2025-03-01", "observed": 52, "expectedLow": 0, "expectedHigh": 102.86268695566544, "isSufficient": true }, { "month": "2025-04-01", "observed": 83, "expectedLow": 0, "expectedHigh": 105.15123887754508, "isSufficient": true }, { "month": "2025-05-01", "observed": 53, "expectedLow": 2.3864828583816386, "expectedHigh": 109.33744226553034, "isSufficient": true }, { "month": "2025-06-01", "observed": 70, "expectedLow": 4.435670568959576, "expectedHigh": 109.88278780047273, "isSufficient": true }, { "month": "2025-07-01", "observed": 178, "expectedLow": 16.08511995248632, "expectedHigh": 177.88168377555203, "isSufficient": true }, { "month": "2025-08-01", "observed": 65, "expectedLow": 22.40961319617856, "expectedHigh": 159.29483096968434, "isSufficient": true }, { "month": "2025-09-01", "observed": 84, "expectedLow": 19.05480768519522, "expectedHigh": 158.50928459077542, "isSufficient": true }, { "month": "2025-10-01", "observed": 160, "expectedLow": 28.700281507932434, "expectedHigh": 142.64924592449017, "isSufficient": true }, { "month": "2025-11-01", "observed": 39, "expectedLow": 31.23604978931492, "expectedHigh": 164.2244131158308, "isSufficient": true }, { "month": "2025-12-01", "observed": 151, "expectedLow": 11.605477967377086, "expectedHigh": 164.98142369733353, "isSufficient": true }, { "month": "2026-01-01", "observed": 40, "expectedLow": 24.155569728420165, "expectedHigh": 222.66379764654033, "isSufficient": true }, { "month": "2026-02-01", "observed": 79, "expectedLow": 0, "expectedHigh": 170.0424130258679, "isSufficient": true }, { "month": "2026-03-01", "observed": 32, "expectedLow": 3.0295757176421967, "expectedHigh": 177.2513529441242, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "JEY (Plate, Bone) has two findings, most consequential first. 1 first-time filer in the last 12 months, Southern Medical (Pty) , Ltd (K253373). The code is crowded, scoring 71 of 100 — 99 companies hold a clearance here and 4 arrived in the last 12 months (JEY:crowding).", "severity": 41, "factors": [ { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, Southern Medical (Pty) , Ltd.", "recordIds": [ "K253373" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 71 of 100 — 99 companies hold a clearance here and 4 arrived in the last 12 months", "recordIds": [ "JEY: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%3AJEY" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJEY" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJEY" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJEY" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJEY" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJEY" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJEY" } ], "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": "2026-08-11T13:51:45.717Z" }