Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
NCT07245719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-04-22
Summary
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Conditions
- Zygomatic Fractures
- Orbital Fractures
- Maxilla Fractures
- Facial Fractures
Interventions
- DEVICE
-
Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
The Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries.
Sponsors & Collaborators
-
Stryker Craniomaxillofacial
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-28
- Primary Completion
- 2026-03-27
- Completion
- 2026-03-27
- FDA Device
- Yes
Countries
- United States
Study Locations
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