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The Exceed™ Biplanar Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Exceed™ Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The Exceed™ Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Exceed™ Biolanar Expandable Interbody System is a lumbar intervertebral body fusion device fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implant is provided unexpanded with a nose tapered in both the lateral and vertical planes, and is expanded in situ using the Exceed™ Inserter. The implant has a microscopic roughened surface with micro and nano-scale features on the superior and inferior surfaces for resistance to migration and to facilitate fusion. The implant is provided in different heights, lengths, and lordotic angles to accommodate the anatomical needs for a range of patients, and is designed to accommodate autogenous and/or allogenic bone graft material.

The provided document is a 510(k) summary for a medical device called the "Exceed™ Biplanar Expandable Interbody System," which is an implant for spinal fusion. This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing.

Therefore, the document does not contain information about:

• Acceptance criteria for an AI/CADe device. The device described is a physical implant, not an AI or CADe system.
• A study proving the device meets acceptance criteria related to AI/CADe performance.
• Sample sizes for test sets or data provenance for AI/CADe.
• Number of experts or their qualifications for AI/CADe ground truth establishment.
• Adjudication methods for AI/CADe.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies related to AI assistance.
• Standalone algorithm performance.
• Types of ground truth used for AI/CADe.
• Sample size for training sets or how ground truth was established for training sets in the context of AI.

Instead, the document details:

• Device Name: Exceed™ Biplanar Expandable Interbody System
• Intended Use: Intervertebral body fusion procedures for degenerative disc disease (DDD) in the lumbar spine.
• Materials: Titanium alloy (Ti-6Al-4V ELI)
• Mechanism: Expandable in situ, microscopic roughened surface for migration resistance and fusion.
• Predicate Devices:
  • Leva® Spacer System (Spine Wave, Inc., K153222)
  • DualX® Expanding Titanium Posterior Lumbar Interbody Fusion System (Amplify Surgical, Inc., K222203)
• Performance Data (Non-clinical testing):
  • Static and dynamic axial compression testing per ASTM F2077
  • Static and dynamic compression shear testing per ASTM F2077
  • Subsidence testing per ASTM F2267
  • Particulate and wear analysis per ASTM F1877

Conclusion of the document: The device is substantially equivalent to the predicate devices and does not present any new issues of safety or effectiveness, based on indications for use, technological characteristics, and non-clinical performance testing.

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