Category: Anterior Cervical Discectomy and Fusion
The ACIS® Anterior Cervical Interbody Spacer is a comprehensive system of PEEK cervical interbody spacers and instruments for the ACDF procedure. The ACIS System utilizes a large central lumen to maximize fusion area. This system and is available in three footprints and three sagittal profiles and 8 heights to accommodate various patient anatomies and surgeon preferences. The ACIS System instrumentation is designed to streamline the ACDF procedure. The system includes two instrument options for ACIS Implant insertion that allow for secure, controlled implant delivery.
The ACIS System are anterior cervical interbody fusion devices indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The interior of DePuy Synthes Spine's ACIS System should be packed with autogenous bone graft and implanted via an anterior approach. The DePuy Synthes Spine's ACIS Devices are intended to be used with supplemental fixation.
One of the risks of any surgical procedure is death. Other potential risks which may require additional surgery, include
*These risks can also be associated with general risks of surgery.
DO NOT USE devices that are received in open or damaged packages. DO NOT USE past the expiration date.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous surgery.
The components of this device are manufactured from a radiolucent polymer and a titanium alloy.
|Large axial lumen and lateral windows||Maximizes fusion area through spacer|
|Lateral windows||Offers additional surface area for bone growth|
|Multiple footprint options:
|Choice of implant footprint that best fits the patient’s anatomy and surgeon’s surgical preference|
|Multiple heights (5-12mm)||8 options to restore lost height and allow decompression|
|Three sagittal profiles:
|Anatomical shape options foster proper sagittal alignment|
|Pyramidal teeth||Resists migration forces in all directions|
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.