{ "code": "HTY", "deviceName": "Pin, Fixation, Smooth", "deviceClass": "II", "regulationNumber": "888.3040", "panel": "Orthopedic", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 204, "last12Months": 2 }, "adverseEvents": { "total": 451, "last12Months": 34 }, "reviewDays": { "median": 85, "sampleSize": 204 }, "recalls": { "total": 31, "recent": [ { "resNumber": "Z-3171-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Smith & Nephew, Inc.", "firmAsPublished": "Smith & Nephew, Inc.", "reason": "Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.", "initiated": "2024-07-09" }, { "resNumber": "Z-3172-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Smith & Nephew, Inc.", "firmAsPublished": "Smith & Nephew, Inc.", "reason": "Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.", "initiated": "2024-07-09" }, { "resNumber": "Z-1468-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "Paragon 28, Inc.", "firmAsPublished": "Paragon 28, Inc.", "reason": "Due to Titanium plasma coating not present implant.", "initiated": "2022-05-26" }, { "resNumber": "Z-1011-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "Stryker Corporation", "firmAsPublished": "Stryker GmbH", "reason": "The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing \"Indicated for patients with Nickel sensitivity\" instead of \"Not Indicated for patients with Nickel sensitivity\".", "initiated": "2022-03-28" }, { "resNumber": "Z-0707-2022", "status": "Terminated", "recallClass": "Class II", "firm": "Brasseler USA, Medical L.L.C.", "firmAsPublished": "Brasseler USA, Medical L.L.C.", "reason": "One lot of product was distributed in unsealed packaging", "initiated": "2022-01-28" } ] }, "recentClearances": [ { "kNumber": "K253325", "deviceName": "ZipToe™ Hammertoe Fusion System", "applicant": "Toetal Solutions", "company": "TOETAL SOLUTIONS, INC", "decisionDate": "2025-12-29", "dateReceived": "2025-09-30" }, { "kNumber": "K252657", "deviceName": "Impact PEEK Union Nail System", "applicant": "Nvision Biomedical Technologies, Inc.", "company": "Nvision Biomedical Technologies, Inc.", "decisionDate": "2025-09-19", "dateReceived": "2025-08-22" }, { "kNumber": "K250315", "deviceName": "RONAVIS – FX (FX-001)", "applicant": "AIRS, Inc.", "company": "AIRS, Inc.", "decisionDate": "2025-08-01", "dateReceived": "2025-02-04" }, { "kNumber": "K251362", "deviceName": "PediFlex™ Flexible Nail System", "applicant": "OrthoPediatrics Corp.", "company": "OrthoPediatrics Corp", "decisionDate": "2025-06-24", "dateReceived": "2025-05-01" }, { "kNumber": "K250646", "deviceName": "Impact PEEK Union Nail System", "applicant": "Nvision Biomedical Technologies", "company": "Nvision Biomedical Technologies, Inc.", "decisionDate": "2025-06-11", "dateReceived": "2025-03-04" }, { "kNumber": "K241014", "deviceName": "Biomet Kirschner Wires (K-Wires)", "applicant": "Biomet, Inc.", "company": "Biomet, Inc.", "decisionDate": "2024-05-22", "dateReceived": "2024-04-12" }, { "kNumber": "K231272", "deviceName": "OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail", "applicant": "OSSIO , Ltd.", "company": "OSSIO , Ltd.", "decisionDate": "2023-12-01", "dateReceived": "2023-05-02" }, { "kNumber": "K231147", "deviceName": "Hammerdesis™ Interphalangeal Fusion System", "applicant": "Intelivation", "company": "Intelivation, LLC", "decisionDate": "2023-09-14", "dateReceived": "2023-04-21" }, { "kNumber": "K230750", "deviceName": "OSSIOfiber® Cannulated Trimmable Fixation Nail", "applicant": "OSSIO , Ltd.", "company": "OSSIO , Ltd.", "decisionDate": "2023-09-13", "dateReceived": "2023-03-17" }, { "kNumber": "K231905", "deviceName": "Electro-Spec Steri-Caps", "applicant": "Electro-Spec, Inc.", "company": "Electro-Spec, Inc.", "decisionDate": "2023-08-14", "dateReceived": "2023-06-29" } ], "topApplicants": [ { "name": "Arthrex, Inc.", "count": 13 }, { "name": "OSSIO , Ltd.", "count": 6 }, { "name": "Biomet, Inc.", "count": 5 }, { "name": "Synthes (Usa)", "count": 5 }, { "name": "Bioretec, Ltd.", "count": 4 } ], "topCompanies": [ { "name": "Arthrex, Inc.", "count": 13, "spellings": 1 }, { "name": "OSSIO , Ltd.", "count": 6, "spellings": 1 }, { "name": "Biomet, Inc.", "count": 5, "spellings": 1 }, { "name": "Synthes USA", "count": 5, "spellings": 1 }, { "name": "Bioretec, Ltd.", "count": 4, "spellings": 1 } ], "newEntrants": [ { "name": "TOETAL SOLUTIONS, INC", "since": "2025-12-29", "kNumber": "K253325" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 16, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 13, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 13, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 30, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 27, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 26, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 19, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 17, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 125, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1, "expectedLow": 0, "expectedHigh": 80.40833301797703, "isSufficient": true }, { "month": "2025-02-01", "observed": 2, "expectedLow": 0, "expectedHigh": 66.26538044824878, "isSufficient": true }, { "month": "2025-03-01", "observed": 1, "expectedLow": 0, "expectedHigh": 71.56387035347146, "isSufficient": true }, { "month": "2025-04-01", "observed": 3, "expectedLow": 0, "expectedHigh": 71.6967403858513, "isSufficient": true }, { "month": "2025-05-01", "observed": 2, "expectedLow": 0, "expectedHigh": 66.38474725798334, "isSufficient": true }, { "month": "2025-06-01", "observed": 4, "expectedLow": 0, "expectedHigh": 68.10953257816189, "isSufficient": true }, { "month": "2025-07-01", "observed": 3, "expectedLow": 0, "expectedHigh": 107.01938367808059, "isSufficient": true }, { "month": "2025-09-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 13, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-03-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 7, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "HTY (Pin, Fixation, Smooth) has two findings, most consequential first. 1 first-time filer in the last 12 months, TOETAL SOLUTIONS, INC (K253325). The code is crowded, scoring 70 of 100 — 130 companies hold a clearance here and 2 arrived in the last 12 months (HTY:crowding).", "severity": 41, "factors": [ { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, TOETAL SOLUTIONS, INC", "recordIds": [ "K253325" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 70 of 100 — 130 companies hold a clearance here and 2 arrived in the last 12 months", "recordIds": [ "HTY: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%3AHTY" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHTY" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHTY" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHTY" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHTY" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHTY" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHTY" } ], "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": "2026-08-11T13:51:45.710Z" }