Augmented Reality Surgical Navigation
Device Overview
JALEX partnered with an OEM to develop an augmented reality (AR) navigation system for shoulder arthroplasty. The system ensures surgical accuracy by providing intraoperative visualization and guidance during implantation. Development efforts included the design and integration of instrumentation used for: Humeral Head resection, Glenoid central pin placement, Glenoid reaming and baseplate orientation and positioning. This AR-enabled workflow was engineered to support reproducible surgical execution and accuracy.
Clinical Application:
- Anatomic Shoulder Arthroplasty
- Reverse Shoulder Arthroplasty
Development Timeline
~27 months
Total product development + regulatory clearance
Client Objectives:
- Obtain FDA 510(k) clearance
- Build a comprehensive Quality Management System (QMS) and Design History File (DHF) aligned with the client’s existing systems
- Deliver a fully specified, validated, and commercially ready platform faster than internal development pathways
- Integrate with existing instrumentation systems within the client’s portfolio
Key Project Highlights
- Conducted seven cadaveric labs to support design iteration, surgeon feedback, and validation
- Completed a full Design History File (DHF) and Quality Management System (QMS) for client transfer
- Ensured all components, testing, and documentation met FDA regulatory requirements for safety and performance as well as internal OEM requirements
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