510(k) K181732

InterSpace Knee Extra-Large Size, InterSpace Knee ATS by Tecres S.P.A. — Product Code JWH

K181732 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "InterSpace Knee Extra-Large Size, InterSpace Knee ATS". The FDA issued a decision of Substantially Equivalent on April 27, 2019. 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. Tecres S.P.A. has at least 10 other 510(k) clearances on record.