510(k) K251453

Arthrex iBalance Partial Knee System by Arthrex, Inc. — Product Code HSX

K251453 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex iBalance Partial Knee System". The FDA issued a decision of Substantially Equivalent on July 1, 2025. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Arthrex, Inc. has at least 10 other 510(k) clearances on record.