510(k) K171269

X-PSI Knee System by Orthosoft Inc (D/B/A Zimmer Cas) — Product Code JWH

K171269 is an FDA 510(k) premarket notification submitted by Orthosoft Inc (D/B/A Zimmer Cas) for the device "X-PSI Knee System". The FDA issued a decision of Substantially Equivalent on Dec 28, 2017. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Orthosoft Inc (D/B/A Zimmer Cas) has 13 other 510(k) clearances on record.