Q Pedicle Instruments

compatibility, technological characteristics, principles of operation, manufacturing process, materials,
sterilization, disinfection, or cleaning, additional non-clinical testing is not required. A risk assessment was
conducted for the labeling changes to confirm the subject devices do not introduce new issues of safety
or effectiveness.

Therefore, no new or different questions of safety and effectiveness have been raised that pose a
significant risk to the safety or effectiveness of the subject device.

Special 510(k) - K260546

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The Q Pedicle Instruments do not include software. When navigated, they are used with Stryker's Spine
Guidance 5 Software.
8 Summary of Clinical Testing
No clinical testing was required to support this submission.

VB Spine Q Pedicle Instruments are intended to be used as accessories to Stryker's Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of VB Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker's Spine Guidance System.

The Q Pedicle Instruments include Q Taps and Q Screwdrivers. The Q Pedicle Instruments are intended to be used to facilitate pedicle preparation and screw placement of VB Spine implants. These instruments are designed to be compatible with Stryker's Spine Guidance 5 Software and Mako Spine System.