Prestige LP Cervical Disc System

• • Terminated Z-1641-2018 FDA Class II ·initiated 13 Mar 2018

  The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.

Trade name

Prestige LP Cervical Disc

Generic name

Prosthesis, intervertebral disc

PMA number

P090029 ↗

FDA product code

MJO

Device class

Class III

Advisory committee

Orthopedic

FDA decision

APPR Approved

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• What specific cervical spine levels can the Prestige LP Cervical Disc System be used to replace, and what conditions does it address?

  The Prestige LP Cervical Disc System is designed for single-level reconstruction between vertebrae C3 and C7. It is intended to replace a damaged or degenerated disc caused by conditions such as herniated nucleus pulposus, spondylosis (with osteophytes), or visible loss of disc height. It addresses intractable radiculopathy (arm pain or neurological deficits), myelopathy, or associated neck pain when conservative treatments have failed and patients have either progressed despite non-operative care or failed at least six weeks of non-operative treatment.

• How is the Prestige LP Cervical Disc System supplied, and is it intended for single-use or reusable?

  The Prestige LP Cervical Disc System is supplied sterile and is explicitly intended for single-use only. This ensures patient safety and compliance with sterile medical device protocols, preventing cross-contamination or reuse-related risks.

• What surgical approach is required to implant the Prestige LP Cervical Disc System, and why?

  The Prestige LP Cervical Disc System is implanted via an anterior surgical approach, meaning the procedure is performed from the front of the neck. This approach is chosen because it provides direct access to the cervical spine disc space, allowing for precise placement of the prosthetic disc while minimizing disruption to surrounding tissues.

• Are there multiple sizes available for the Prestige LP Cervical Disc System, and how does this accommodate patients?

  Yes, the Prestige LP Cervical Disc System comes in multiple sizes, each corresponding to specific anatomical requirements. This variety ensures compatibility with the cervical spine’s biomechanical needs across different patients, allowing for optimal disc reconstruction and load distribution at the treated level.

• What regulatory pathway does the Prestige LP Cervical Disc System follow, and what does this mean for clinicians?

  The Prestige LP Cervical Disc System follows the FDA Premarket Approval (PMA) pathway, classified as a Class III device. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in skeletally mature patients with specific cervical spine conditions. Clinicians can rely on this approval as evidence of the device’s compliance with stringent regulatory standards.