IFU Highlights
FDA PMA Approval
The Synergy Disc is FDA approved for use in the U.S. for single-level indications at C3–C7.
FDA approval of the Synergy Disc is supported by clinical evidence generated through a rigorous prospective clinical study conducted under an Investigational Device Exemption (IDE) in the U.S. The company also has over 10 years of clinical experience with the Synergy Disc outside the United States in more than 10 countries, where the device has been commercially available and implanted in thousands of patients.
10+
years of clinical experience
10+
countries where commercially available
1,000s
of patients implanted
Indications
The Synergy Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3–C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Synergy Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Synergy Disc.
Contraindications
The Synergy Disc should not be implanted in patients with the following conditions:
- Tumor or trauma
- Intractable radiculopathy or myelopathy necessitating surgical treatment at more than one cervical level
- Allergy or sensitivity to the implant materials (e.g., titanium and polyethylene)
- Bridging osteophytes
- Radiographic instability on lateral, coronal, or flexion/extension radiographs: translation greater than 3.5 mm and/or greater than 11 degrees of angular difference from either adjacent segment
- Facet joint degeneration
- Active systemic or local infection
- Osteoporosis defined as Dual-Energy X-ray Absorptiometry (DEXA) bone mineral density T-score less than -2.5
- Advanced cervical spine conditions or diseases at the index level other than those included in the Indications for Use (e.g., rheumatoid arthritis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), ankylosing spondylitis)
For complete indications, contraindications, warnings, and precautions, please refer to the electronic Instructions for Use (eIFU).
