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The SDS Growing Rod is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.

The SDS Growing Rod is an implant designed to correct and actively lengthen the spine in children with early onset spinal deformities while allowing growth, without the need for re-operations or other interventions. This is achieved by a spinal construct with one or two springs and sliding bearings. The spring provides a distraction force to correct the spinal curve while the sliding bearing is designed to enable growth by allowing displacement of one rod with respect to the other rod.

The SDS Growing Rod is available with 5.5 mm rods. Two configurations of the SDS Growing Rod are possible: hybrid and bilateral. The SDS Growing Rod is delivered sterile and is for single use only. The intended lifetime of the SDS Growing Rod while allowing growth is up to 5 years. The SDS Growing Rod is removed or locked after the treatment is completed.

The SDS Growing Rod is composed out of the following components:

• Titanium alloy springs with UHMWPE bushings
• Titanium alloy Axial Sliding Bearing with UHMWPE bearings
• Titanium alloy Polyaxial Sliding Bearing with UHMWPE bearings
• Titanium alloy buttress
• CoCr rods
• Titanium alloy C-Clamp

The SDS Growing Rod is used in combination with:

• Dedicated instrument set
  • Spring Compressor
  • Spring Locker
  • Torque Limiting Handle 9Nm
  • C-Clamp Forceps
  • SDS Tray
• Pedicle screws for 5.5 mm rods. The SDS Growing Rod is compatible with pedicle screws from the RESPONSE™ 5.5/6.0 mm System (Orthopediatrics) and their dedicated instrumentation for screw placement. Other components of the RESPONSE™ system, such as connectors, hooks, or ancillary fixation elements, may be used within the same spinal construct as clinically indicated. However, these components should not impede the sliding function of the growing rod or integrated spring mechanism.

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