ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty…
FDA 510(k)Class II (US FDA 510(k))
by Stryker GmbH
Identifiers
- 510(k) Number
- K161863 FDA 510(k)
- FDA Product Code
- KWS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3660 FDA 510(k)
- Regulation Number
- 888.3660 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ReUnion Reversible Fracture System (RFX), Reverse Shoulder Arthroplasty (RSA), and Total Shoulder Arthroplasty (TSA) are modular orthopedic implants designed for shoulder joint replacement. These systems are intended for use in shoulder arthroplasty, functioning as hemi, total, or reverse shoulder replacements.
The systems incorporate technologies including X3 highly crosslinked polyethylene, Tritanium 3D porous metal, and SmartLock variable angle locking screws. This device has received FDA 510(k) clearance under K161863.
Frequently asked questions
What are the ReUnion shoulder systems used for?
The ReUnion Reversible Fracture System (RFX), Reverse Shoulder Arthroplasty (RSA), and Total Shoulder Arthroplasty (TSA) are modular orthopedic implants designed to function as hemi, total, or reverse shoulder replacements for patients requiring joint replacement surgery.
What specific technologies are incorporated into these implants?
These systems utilize advanced materials and design features, including X3 highly crosslinked polyethylene for the bearing surfaces, Tritanium 3D porous metal for bone integration, and SmartLock variable angle locking screws for secure fixation.
What is the regulatory status of the ReUnion shoulder systems?
The ReUnion Reversible Fracture System, RSA, and TSA have received FDA 510(k) clearance under K161863, having been determined to be substantially equivalent to existing devices by the FDA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ReUnion RFX - Stryker, ReUnion RFX - Stryker, ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder ..., ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161863 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (1)
- FDA 510(k) K161863 24 fields · synced Sep 25, 2026