Ligament Reconstruction Fixation System
Device Overview
JALEX developed a multi-component fixation system designed to provide temporary stabilization through implants and off-the-shelf non-resorbable sutures. The system supports precise, reliable fixation during arthroscopic procedures.
Clinical Application:
- Arthroscopic Coracoclavicular (CC) Ligament Reconstruction
- Arthroscopic Acromioclavicular (AC) Ligament Reconstruction
Development Timeline
~18 months
Total product development + regulatory clearance
~98 days
FDA 510(k) review and clearance
Client Objectives:
- Achieve FDA 510(k) clearance
- Develop a complete Design History File (DHF)
- Develop a complete Quality Management System (QMS)
- Update system implants and instrumentation to meet clinical expectations
Key Project Highlights
- Collaborated closely with an international client to guide full device development
- Coordinated with an accredited testing facility to implement an optimized testing strategy in support of regulatory submission
- Ensured all components and documentation met FDA expectations for safety and performance
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