510(k) K905810

NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION by Joint Medical Products Corp. — Product Code JWH

K905810 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 12, 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. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.