Medical Devices

SpineSmith designs and engineers innovative technologies focused on the stabilization and treatment of spinal and orthopedic disorders. We are dedicated to pioneering new solutions and rethinking current implants being marketed to spine surgeons.

CIMPLICITY™

Cervical Made Simple.

The Cimplicity System is an Anterior Cervical Interbody Fusion Device.

Cimplicity is FDA cleared under the following:

• K073320 Cervical Interbody Fusion Device for use with Autogenous Bone Graft.
• K080971 Vertebral Body Replacement Device (VBR) and and Intervertebral Body Fusion Device for use with autograft or allograft bone.

The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level (from the C2-C3 disc to the C7-T1 disc). Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach.

Cimplicity Allograft Plug is a minimally manipulated tissue adapted to the spine. The dense cancellous allograft “plug” provides surgeons an implant “fill” option that eliminates the need to harvest autograft iliac crest. This custom-designed plug increases operating room efficiency and surgery speed.

CIMPLICITY Hardware

Benefits

• One set of Instruments

Product Information

CIMPLICITY

FDA Clearance

K073320
K080971

Synthetic PEEK®

• Mechanical strength superiority
• Radiolucent with Tantalum Markers
• Two sizes 13mm(W) x 10mm(D) or 17mm(W) x 14mm(D)

Cancellous Allograft Plug

• Demineralized Cancellous Bone
• Freeze Dry Packaging (reconstitute in surgery at surgeon's discretion)
• Optional packaged separately
• Implant fill option eliminates the need to harvest autograft iliac crest

CIMPLICITY Instrumentation

Benefits

• One set of instrumentation for allograft and synthetic implants
• Multiple implant holder options
• Wide variety of rasps and trial options available

Kit Configuration

STOP
STOPLESS
CANCELLOUS PLUG

Implant Holders

• Three options work in identical fashion with Cortical Allograft Bone and Synthetic PEEK
• Identical instrumentation interfaces to PEEK implant

Rasps, Trials and Pushers

• "Stop" and "Stopless" Styles
• "Stop" Style design straddles Caspar Pins for efficient uninhibited usage