510(k) K913492

KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM by Kirschner Medical Corp. — Product Code JWH

K913492 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 1991. 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.