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Friday, Aug 23
Zimmer Holdings gets FDA 510K clearance for its Patient-Specific Instruments Shoulder system in the US
- Zimmer Holdings (ZMH -0.1%) says it's received FDA 510(k) clearance to market its Patient Specific Instruments Shoulder system to complement its Trabecular Metal Reverse Shoulder system for reverse shoulder arthroplasty procedures.
- The system uses 3-D visualization software to assist surgeons in creating a customized surgical plan for each patient, and then provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the personalized surgical plan.
- It has been available to a limited number of surgeons in Europe since May, and now with the clearance, it will be available to shoulder surgeons across the U.S.