Shoulder Arthroplasty Instrumentation Advancements
Device Overview
JALEX partnered with an OEM to enhance the surgical workflow of a commercialized shoulder arthroplasty system. The project focused on designing and developing next-generation instrumentation including a new reamer, reaming guide, driver, and inserter/remover, to improve precision, usability, and surgical efficiency.
Clinical Application:
- Anatomic Shoulder Arthroplasty
- Reverse Shoulder Arthroplasty
Development Timeline
~20 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
- Update system instrumentation to meet clinical expectations
Key Project Highlights
- Conducted five 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
Explore More Case Studies
See how JALEX delivers across device types and specialties.