Knee+

Knee+ is a surgical navigation system for primary total knee replacement that uses a head-mounted display (smart glasses) with integrated camera and software to assist surgeons in determining proper alignment axes and positioning cutting guides. The system displays intraoperative information to guide bone resections but must be used alongside traditional surgical methods.

The main change from the predicate device (K243975) is a simplified execution platform reduced from 4 components to 2 (smart glasses with integrated camera and external battery). The surgical protocol, tracking system technology, head-mounted display approach, and claimed accuracy for cut orientation remain identical to the predicate device.

ASTM F2554 for repeatability and accuracy; IEC 62366-1 for user needs validation; IEC 62304 for software verification and validation; IEC 60601-1, IEC 60601-1-2, EN 62368-1, and ETSI EN 301 489 series for EMC and electrical safety; ISO 10993 for biocompatibility assessment.

Knee+ is substantially equivalent because it has identical intended use, indications for use, and core technological characteristics as its predicate K243975. Performance testing demonstrates the simplified execution platform achieves the same specifications and safety profile as the predicate. The hardware simplification and minor modifications do not alter surgical use or raise new safety and effectiveness questions.