510(k) K920396

KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM by Kirschner Medical Corp. — Product Code JWH

K920396 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 1992. 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. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.