Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Binder Biomedical
• Logic Standalone Intervertebral Body Fusion Device, K130641

Corentec
• Lospa IS Pedical Screw, Straight and Pre-bent Rods, K132644

Jeil Medical
• Arix Foot System, K131311

NovoSource
• NovoKnee Total Knee, K131398

ORTHOSoft
• CAS PSI Knee System, K131409

Renovis Surgical
• Bipolar Hip System, K131354
• S128 Anterior Lumbar Interbody Fusion System, K131122

Tyber Medical
• Interbody System: ACIF, ALIF, PLIF, TLIF, DLIF, K130573*

Vertebral Technologies
• Interfuse L Intervertebral Body Fusion Device, K131540

Source: FDA 510(k) Releasable Database, 9/13

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