Device Information

Device Specifications

The ADIRA Lateral Plate System is available in 4-hole, 2-hole, and 1-hole thoracolumbar plates of various sizes to match different patient anatomies and surgical needs. The plates are used with bone screws and can be attached to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine. Additionally, the plates can connect with specific lateral lumbar interbody fusion devices to create a plate-spacer assembly. The system provides temporary stabilization and aids in spinal fusion.

Indications

The ADIRA Lateral Plate System is intended to treat thoracolumbar spinal instability resulting from conditions like fracture, tumor, degenerative disc disease (DDD), scoliosis, kyphosis, lordosis, and spinal stenosis. It can also be used to stabilize allograft or autograft at one spinal level to aid in spinal fusion.

Intended Use

The ADIRA Plates treat patients with thoracolumbar instability (T1-L5), degenerative disc disease, and related conditions. The devices can be used with autograft and/or allogenic bone grafts for skeletally mature patients who have undergone six months of non-operative treatment.

Availability

Prescription use only (21 CFR 801 Subpart D).

Study Results

• Nonclinical and Safety Testing: Mechanical testing was conducted for static and dynamic compression bending and static torsion. Expulsion testing was also performed. The ADIRA implants have similar performance data as predicate devices. Simulations indicated that the devices are comparable in terms of MR compatibility.

Regulatory Information

• Regulation Number: 21 CFR 888.3060 (Spinal Intervertebral Body Fixation Orthosis)
• Regulatory Class: Class II
• Product Code: KWQ, OVD, MAX
• 510(k) Number: K233735

The ADIRA Lateral Plate System follows general controls and quality system regulations under 21 CFR Part 820. This includes design controls, nonconforming product management, and corrective and preventive actions.

Manufacturer Information

• Name: Globus Medical Inc.
• Address: 2560 General Armistead Ave, Audubon, PA 19403
• Contact Person: Jennifer Antonacci, Group Manager, Regulatory Affairs

Predicate Device Information

• Primary Predicate Device: PLYMOUTH Thoracolumbar Plate (K120092)
• Additional Predicate Devices:
  • PLYMOUTH Thoracolumbar Plate (K181846)
  • InterContinental Plate-Spacer (K103382, K203278)
  • 4WEB Lateral Spine Truss System Plating (K203065)
  • ELSA Spacers (K161379, K203278)
• Reference Devices: NuVasive Thoracolumbar Interbody Systems (K203714)

The predicate devices serve similar functions in stabilizing the spine, and the ADIRA plates have slight modifications to accommodate various patient anatomies.

Implications

The ADIRA Lateral Plate System provides a flexible solution for spinal stabilization. It can be integrated with several interbody devices, allowing for diverse surgical applications. This flexibility enhances spinal fusion procedures in patients with thoracolumbar instability.

References

1. ADIRA Lateral Plate System. K233735. Globus Medical Inc.: FDA Summary  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233735 
2. https://www.globusmedical.com/