510(k) K090705

BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT by Ortho Development Corp. — Product Code JWH

K090705 is an FDA 510(k) premarket notification submitted by Ortho Development Corp. for the device "BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT". The FDA issued a decision of Substantially Equivalent on October 9, 2009. 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. Ortho Development Corp. has at least 10 other 510(k) clearances on record.