← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K961421 # SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM (K961421) _Synthes (Usa) · JEY · Jun 26, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K961421 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md) - **Decision Date:** Jun 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4760 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures. ## Device Story Plate and screw system for mandible trauma and reconstruction; plates attach to bone via self-tapping cortex or locking screws; features internally threaded compression screw holes; instrumentation includes threaded drill guides for drill bit alignment and insert screws to protect threaded holes during plate bending; device provided non-sterile; requires moist heat sterilization per AAMI guidelines; used by surgeons in clinical settings; provides mechanical stabilization of bone segments. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: unspecified metal plate and screw system; dimensions: 2.4 mm system with 2.4 mm - 3.0 mm locking screws; drill guides (1.5 mm - 2.5 mm bores); sterilization: moist heat (steam) per AAMI guidelines; non-sterile delivery. ## Regulatory 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. ## Predicate Devices - Synthes 2.7 mm Reconstruction Plate System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} SYNTHES K961421 Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary] SYNTHES (USA) 1690 Russell Road Paoli, PA 19301 JUN 26 1996 (610) 647-9700 Contact: Angela Silvestri April 1996 Device: Synthes 2.4 mm Universal Locking Plate System, as compared to Synthes 2.7 mm Reconstruction Plate System. The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures. The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws. The following instrumentation is used with the 2.4 mm ULPS: Threaded Drill Guide is used for guiding the drill bit to bone by threading the tip into the plate's screw hole. The bore (inside diameter) of the drill guide is dependent upon the screw size when selected since each screw diameter requires a specific drill diameter. They are available with bores from 1.5 mm to 2.5 mm. 2.4 mm Insert Screw is used by the surgeon while bending the plate to avoid deforming the threaded screw holes. The inserts are screwed into the plate holes prior to bending and removed once the bending operation is complete. Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance." Based on mechanical test results, we believe that the devices are at least equivalent. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K961421](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K961421) **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. 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