← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K953806 # SYNTHES (USA) MIDFACIAL SYSTEM (K953806) _Synthes (Usa) · JEY · Mar 8, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K953806 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md) - **Decision Date:** Mar 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4760 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. ## Device Story Plate and screw system for midfacial/craniofacial fixation; manufactured from commercially pure (CP) titanium; includes various plate configurations and 1.3 mm or 1.7 mm self-tapping screws; low-profile design. Used in clinical settings for trauma, reconstruction, and orthognathic surgery. Provided non-sterile; requires moist heat sterilization by user. Surgeon attaches plates to bone to stabilize fractures or reconstructive sites. Benefits include structural stabilization of bone segments. ## Clinical Evidence Bench testing only. Mechanical test results confirm equivalence to predicate system. ## Technological Characteristics Commercially pure (CP) titanium plates and screws; 1.3 mm and 1.7 mm self-tapping screw diameters; low-profile design; non-sterile; requires moist heat sterilization. ## 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 - Howmedica Luhr Pan Fixation 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 K953806 Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary] SYNTHES (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri August 9, 1995 Device: Synthes Midfacial System, as compared to the Howmedica Luhr Pan Fixation System. The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile. The Howmedica Luhr Pan Fixation System, manufactured from Vitallium® alloy, is also intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are also available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.5 mm self-tapping screws, with a low plate/screw profile. Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended. Based on mechanical test results, the Synthes Midfacial System is equivalent to the Howmedica Luhr Pan Fixation System. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K953806](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K953806) **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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