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Indications for Use: The RIO® is intended to assist the surgeon in providing software-defined spatialboundaries for orientation and reference information to anatomical structures during orthopedic procedures.The RIO® is indicated for use in surgical knee procedures, in which the use ofstereotactic surgery may be appropriate, and where reference to rigid anatomical bonystructures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.

RESTORIS® MCK Uni components are for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis
• Revision of previous unsuccessful unicompartmental knee replacement
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

These components are single use only and are intended for implantation with bone cement.

RESTORIS® MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS® MCK is for single use only and is intended for implantation with bone cement.

RESTORIS® MCK PF is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

RESTORIS® is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or posttraumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

The RIO® is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO® is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement and/or patellofemoral knee replacement and Total Hip Arthroplasty (THA).

HIPAA Warning: MAKO Surgical Corp. is not a business associate under the Health Insurance Portability and Accountability Act (HIPAA) and has taken steps to ensure that it does not receive access to patient protected health information (PHI) as defined by HIPAA unless such access is for a permissible purpose under HIPAA.  Accordingly, the uploading, posting or exchange of any patient protected health information on MAKOlink™ is prohibited. Your use of MAKOlink™ is conditioned upon your compliance with this policy and MAKO reserves the right to remove and exclude any non-complaint materials or users. For information about what constitutes PHI, please visit http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.