510(k) K980999

ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT by Instrument Makar, Inc. — Product Code JWH

K980999 is an FDA 510(k) premarket notification submitted by Instrument Makar, Inc. for the device "ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT". The FDA issued a decision of Substantially Equivalent on November 6, 1998. 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. Instrument Makar, Inc. has at least 10 other 510(k) clearances on record.