Project
Stryker ReUnion RSA Teardown
Reverse-engineering a Class II reverse shoulder arthroplasty system end-to-end.
Summary
A full-system teardown of a reverse shoulder implant: disease state → biomechanics → requirements → regulatory → manufacturing → outcomes.
Use case
Built to be a repeatable benchmarking framework for future device design, not just documentation of one implant.
Who it's for
- biomedical engineers
- device designers
- students
Stack
- Biomechanics
- Materials (Ti-6Al-4V, Tritanium, X3 UHMWPE)
- FDA 510(k)
- QFD
- DFx / DfE
Case study
What it is
Stryker's ReUnion RSA is a Class II reverse shoulder arthroplasty system, indicated for patients with rotator cuff tear arthropathy in which the native joint no longer has the soft-tissue stabilizers required for a conventional total shoulder replacement.
This project reverse-engineers the device end to end: the underlying disease state, the geometric inversion that allows the deltoid to compensate for a non-functional rotator cuff, the materials system (Ti-6Al-4V, Tritanium 3D porous metal, and X3 highly crosslinked UHMWPE), the FDA 510(k) clearance pathway, the Quality Function Deployment targets, and the manufacturing and Design for Environment decisions that support them.
Objective
The objective was not to document the implant, but to develop a repeatable benchmarking framework — disease state → biomechanics → requirements → regulatory → manufacturing → outcomes — that can be applied in reverse to the design of future medical devices.