Published October 31, 2025
Stryker Craniomaxillofacial has initiated a retrospective post-market follow-up study for its Surgeon iD Mandible Reconstruction Plates, aiming to ensure optimal safety and performance. This research focuses on patients impacted by mandible fractures or requiring mandibular reconstruction. Stakeholders in clinical, quality, and regulatory fields may find this study essential for evaluating the device’s regulatory compliance and effectiveness in surgical applications.
The study, officially listed on ClinicalTrials.gov, is actively recruiting participants, signaling an opportunity for clinicians and researchers to contribute to the growing body of evidence supporting medical device evaluation and post-market surveillance.
For those interested in this topic, this article delves into the study’s scope, target population, and implications for medical device regulation.
What are the details of the study?
The clinical trial, sponsored by Stryker Craniomaxillofacial, revolves around evaluating the performance and safety profile of the Surgeon iD Mandible Reconstruction Plate as part of its post-market surveillance efforts. This device is specifically designed for clinical applications related to mandible fractures and mandibular reconstructions. The study is currently recruiting participants, providing a unique chance to further assess the device’s impact under real-world conditions.
Post-market surveillance is a critical phase in medical device regulation as it ensures that products continue to function as intended after widespread clinical adoption. The study’s findings are expected to contribute valuable data regarding safety, efficacy, and long-term performance outcomes.
How does the Surgeon iD Mandible Plate perform?
The Surgeon iD Mandible Reconstruction Plate is tailored for complex mandibular procedures. It aims to provide optimal support for the reconstruction of the mandible in scenarios of trauma or anatomical restoration.
According to the manufacturer, the plate’s design leverages advanced materials to ensure durability while maintaining biocompatibility. These plates are intended to improve patient outcomes and surgical precision, with features that enhance ease of use for surgeons.
This post-market study critically examines the in-use performance of the device while ensuring compliance with safety standards outlined by global medical device regulations, such as those stipulated in the EU MDR and FDA guidelines.
What does this mean for the medical device industry?
Research and development initiatives, such as Stryker’s retrospective study, are vital in aligning product performance with regulatory requirements. It demonstrates Stryker’s commitment to evidence-based improvements, which strengthen patient safety and regulatory compliance.
Post-market surveillance studies also play an essential role in identifying areas needing improvement, allowing manufacturers to refine products or recognize risks early in their lifecycle.
For industry professionals, clinical trials like this provide key insights for future device development. Enhanced monitoring leads to improved standardization and innovation, ensuring next-generation devices meet rigorous clinical and operational standards.
FAQ
- 1. What conditions are targeted by this study?
The study focuses on mandible fractures and mandibular reconstruction. - 2. What does post-market surveillance involve?
Post-market surveillance assesses the device’s performance and safety after its commercial release, ensuring continued compliance with medical device regulations. - 3. How can stakeholders contribute?
Stakeholders, including clinicians and researchers, can join the study by participating in recruitment efforts or monitoring results. - 4. Where can I learn more about the study?
Visit the official ClinicalTrials.gov page for detailed information on the study: ClinicalTrials.gov Study NCT07221916.
Conclusion and implications
Stryker’s retrospective study on the Surgeon iD Mandible Reconstruction Plate highlights significant steps toward improving patient care and compliance with regulatory requirements. For clinical, quality, and regulatory teams, this initiative illustrates the importance of ongoing device evaluation, presenting opportunities for collaboration and innovation in the medical device industry.
Disclaimer
This content is intended for informational purposes only and does not constitute professional regulatory advice. Readers seeking professional guidance should consult directly with medical device regulatory experts.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07221916?term=medical+device