Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4760](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4760) → JEY — Plate, Bone # JEY · Plate, Bone _Dental · 21 CFR 872.4760 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY ## Overview - **Product Code:** JEY - **Device Name:** Plate, Bone - **Regulation:** [21 CFR 872.4760](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4760) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **Implant:** yes ## Identification A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 292) Showing 20 most recent of 292 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252246](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K252246.md) | Leforte MMF System | Jeil Medical Corporation | Apr 2, 2026 | SESE | | [K253373](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K253373.md) | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | Dec 19, 2025 | SESE | | [K251441](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K251441.md) | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | Nov 7, 2025 | SESE | | [K241314](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K241314.md) | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | Aug 16, 2024 | SESE | | [K240651](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K240651.md) | MRI Universal | Stryker Leibinger GmbH & Co KG | Jul 12, 2024 | SESE | | [K233874](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K233874.md) | tmCMF Solution | Techmah Cmf | Jul 11, 2024 | SESE | | [K232889](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K232889.md) | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | Apr 30, 2024 | SESE | | [K232350](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K232350.md) | Stryker Facial iD System | Stryker Craniomaxillofacial | Jan 13, 2024 | SESE | | [K230398](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K230398.md) | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | Sep 26, 2023 | SESE | | [K230733](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K230733.md) | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | Aug 5, 2023 | SESE | | [K222650](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K222650.md) | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | Dec 9, 2022 | SESE | | [K220360](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K220360.md) | Tandry CMF Plate System | Microware Precision Co., Ltd. | Nov 10, 2022 | SESE | | [K221855](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K221855.md) | Universal CMF System | Stryker Leibinger GmbH & Co KG | Nov 9, 2022 | SESE | | [K210731](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K210731.md) | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | Jul 18, 2022 | SESE | | [K213777](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K213777.md) | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | Feb 4, 2022 | SESE | | [K202969](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K202969.md) | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | Aug 5, 2021 | SESE | | [K202918](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K202918.md) | OsteoSync™ Ti Dental Mesh | Sites Medical, LLC | Jul 14, 2021 | SESE | | [K203282](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K203282.md) | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | May 19, 2021 | SESE | | [K193280](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K193280.md) | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | Feb 12, 2021 | SESE | | [K201944](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K201944.md) | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | Synthes (USA) Products, LLC | Sep 10, 2020 | SESE | ## Top Applicants - Synthes (Usa) — 38 clearances - Bioplate, Inc. — 16 clearances - KLS-Martin L.P. — 15 clearances - Walter Lorenz Surgical, Inc. — 15 clearances - Stryker — 13 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com