Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

Indications for the MRS Stems and lntercalary Stems presented in K952970:

This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.

The lntercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection, or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581 ):

Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):

Proximal femoral reconstruction secondary to:

o Trauma

o Failed previous prosthesis

o Tumor resection

Indications for the Modular Replacement System Cemented Stems (presented in K040749):

Femoral and/or proximal tibial replacement due to:

o Trauma

o Failed previous prosthesis

o Tumor resection

Indications for the Modular Rotating Hinge Knee System (cleared in K002552)

The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue.

Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.