{ "code": "HRS", "deviceName": "Plate, Fixation, Bone", "deviceClass": "II", "regulationNumber": "888.3030", "panel": "Orthopedic", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 1319, "last12Months": 59 }, "adverseEvents": { "total": 6192, "last12Months": 1502 }, "reviewDays": { "median": 86, "sampleSize": 1319 }, "recalls": { "total": 286, "recent": [ { "resNumber": "Z-2532-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Acumed LLC", "firmAsPublished": "Acumed LLC", "reason": "Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.", "initiated": "2026-05-28" }, { "resNumber": "Z-1592-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "I.T.S. GmbH", "firmAsPublished": "I.T.S. GmbH", "reason": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).", "initiated": "2026-01-23" }, { "resNumber": "Z-1593-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "I.T.S. GmbH", "firmAsPublished": "I.T.S. GmbH", "reason": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).", "initiated": "2026-01-23" }, { "resNumber": "Z-1594-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "I.T.S. GmbH", "firmAsPublished": "I.T.S. GmbH", "reason": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).", "initiated": "2026-01-23" }, { "resNumber": "Z-1595-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "I.T.S. GmbH", "firmAsPublished": "I.T.S. GmbH", "reason": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).", "initiated": "2026-01-23" } ] }, "recentClearances": [ { "kNumber": "K261406", "deviceName": "Versalock Proximal Tibial Plating System", "applicant": "GM Dos Reis Industria e Comercio Ltda.", "company": "GM Dos Reis Industria e Comercio Ltda.", "decisionDate": "2026-07-21", "dateReceived": "2026-04-29" }, { "kNumber": "K262032", "deviceName": "TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )", "applicant": "TriMed, Inc.", "company": "TriMed Inc.", "decisionDate": "2026-07-16", "dateReceived": "2026-06-17" }, { "kNumber": "K261191", "deviceName": "Alians Elbow S", "applicant": "Newclip Technics", "company": "NEWCLIP TECHNICS SAS", "decisionDate": "2026-07-08", "dateReceived": "2026-04-13" }, { "kNumber": "K261054", "deviceName": "RibPlate System", "applicant": "Stryker Leibinger GmbH & Co KG", "company": "Stryker Leibinger GmbH & Co. KG", "decisionDate": "2026-07-01", "dateReceived": "2026-03-31" }, { "kNumber": "K261351", "deviceName": "SALGINA 2.5mm Distal Radius System", "applicant": "Bonebridge AG", "company": "Bonebridge AG", "decisionDate": "2026-06-26", "dateReceived": "2026-04-24" }, { "kNumber": "K260958", "deviceName": "I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L", "applicant": "I.T.S. GmbH", "company": "I.T.S. GmbH", "decisionDate": "2026-06-16", "dateReceived": "2026-03-23" }, { "kNumber": "K261207", "deviceName": "Exalta Proximal Tibia Plating System", "applicant": "Tyber Medical, LLC", "company": "Tyber Medical", "decisionDate": "2026-06-12", "dateReceived": "2026-04-13" }, { "kNumber": "K260761", "deviceName": "APTUS Clavicle System 2.8", "applicant": "Medartis AG", "company": "Medartis, Inc.", "decisionDate": "2026-06-05", "dateReceived": "2026-03-09" }, { "kNumber": "K261002", "deviceName": "Pectus Blu System", "applicant": "Biomet Microfixation", "company": "Biomet Microfixation, Inc.", "decisionDate": "2026-06-02", "dateReceived": "2026-03-26" }, { "kNumber": "K261038", "deviceName": "Xpert PFP", "applicant": "Newclip Technics", "company": "NEWCLIP TECHNICS SAS", "decisionDate": "2026-05-29", "dateReceived": "2026-03-30" } ], "topApplicants": [ { "name": "Synthes (Usa)", "count": 87 }, { "name": "Wrightmedicaltechnologyinc", "count": 45 }, { "name": "Arthrex, Inc.", "count": 39 }, { "name": "Smith & Nephew, Inc.", "count": 34 }, { "name": "Medartis AG", "count": 31 } ], "topCompanies": [ { "name": "Synthes USA", "count": 95, "spellings": 3 }, { "name": "Wrightmedicaltechnologyinc", "count": 45, "spellings": 1 }, { "name": "Arthrex, Inc.", "count": 39, "spellings": 1 }, { "name": "Smith & Nephew, Inc.", "count": 37, "spellings": 2 }, { "name": "Medartis, Inc.", "count": 32, "spellings": 2 } ], "newEntrants": [ { "name": "Chest Wall Innovations, Inc.", "since": "2026-04-24", "kNumber": "K260411" }, { "name": "Actis Medical Pty., Ltd.", "since": "2026-04-10", "kNumber": "K260090" }, { "name": "Met One Technologies, LLC", "since": "2026-02-12", "kNumber": "K251732" }, { "name": "Gm Dos Reis Industria E Comercio", "since": "2025-12-19", "kNumber": "K251050" }, { "name": "HyperFlex Medical Inc", "since": "2025-12-11", "kNumber": "K252997" }, { "name": "Maxxos Medical GmbH", "since": "2025-09-08", "kNumber": "K251892" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 103, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 100, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 212, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 170, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 294, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 161, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 132, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 165, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 121, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 188, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 138, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 181, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 223, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 167, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 145, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 111, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 120, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 177, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 164, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 119, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 116, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 185, "expectedLow": 46.050851654841345, "expectedHigh": 203.30086646990785, "isSufficient": true }, { "month": "2025-02-01", "observed": 170, "expectedLow": 54.8530194054254, "expectedHigh": 192.74910976462886, "isSufficient": true }, { "month": "2025-03-01", "observed": 136, "expectedLow": 73.38684104234471, "expectedHigh": 235.9682270573594, "isSufficient": true }, { "month": "2025-04-01", "observed": 210, "expectedLow": 72.88682929567581, "expectedHigh": 236.49540728844616, "isSufficient": true }, { "month": "2025-05-01", "observed": 133, "expectedLow": 88.99118736384762, "expectedHigh": 230.43206328070292, "isSufficient": true }, { "month": "2025-06-01", "observed": 216, "expectedLow": 84.09401517818675, "expectedHigh": 230.33207763282263, "isSufficient": true }, { "month": "2025-07-01", "observed": 230, "expectedLow": 140.68198447188172, "expectedHigh": 406.81306997675165, "isSufficient": true }, { "month": "2025-08-01", "observed": 246, "expectedLow": 104.4617757465605, "expectedHigh": 289.76770948889305, "isSufficient": true }, { "month": "2025-09-01", "observed": 129, "expectedLow": 126.85571523007665, "expectedHigh": 320.8229871591673, "isSufficient": true }, { "month": "2025-10-01", "observed": 173, "expectedLow": 88.89551674190571, "expectedHigh": 298.5534698375625, "isSufficient": true }, { "month": "2025-11-01", "observed": 209, "expectedLow": 74.10960999001388, "expectedHigh": 262.90858730860367, "isSufficient": true }, { "month": "2025-12-01", "observed": 246, "expectedLow": 100.69472737806535, "expectedHigh": 299.48081206321376, "isSufficient": true }, { "month": "2026-01-01", "observed": 117, "expectedLow": 144.67892579218434, "expectedHigh": 351.9875673759656, "isSufficient": true }, { "month": "2026-02-01", "observed": 166, "expectedLow": 70.11355167938203, "expectedHigh": 283.70360913806144, "isSufficient": true }, { "month": "2026-03-01", "observed": 256, "expectedLow": 73.47165904411922, "expectedHigh": 305.2413851203473, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "HRS (Plate, Fixation, Bone) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2532-2026, Z-1592-2026, Z-1593-2026, Z-1594-2026, Z-1595-2026). 6 first-time filers in the last 12 months, including Chest Wall Innovations, Inc. and Actis Medical Pty., Ltd (K260411, K260090, K251732, K251050, K252997). The code is crowded, scoring 100 of 100 — 301 companies hold a clearance here and 59 arrived in the last 12 months (HRS:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2532-2026", "Z-1592-2026", "Z-1593-2026", "Z-1594-2026", "Z-1595-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "6 first-time filers in the last 12 months, including Chest Wall Innovations, Inc. and Actis Medical Pty., Ltd.", "recordIds": [ "K260411", "K260090", "K251732", "K251050", "K252997" ], "severity": 46 }, { "kind": "crowding", "detail": "the code is crowded, scoring 100 of 100 — 301 companies hold a clearance here and 59 arrived in the last 12 months", "recordIds": [ "HRS: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%3AHRS" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHRS" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHRS" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHRS" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHRS" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHRS" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHRS" } ], "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": "2026-08-11T13:51:45.709Z" }