2 Hole Lateral Plating System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K172131 ↗

FDA product code

KWQ

Device class

Class II

Regulation

21 CFR Part 888.3060

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Arx 13-5550-13

  Class II

  FDA 510(k) K200070 Active Cleared 23 Apr 2020 GUDID on market

• Arx 13-6540-13

  Class II

  FDA 510(k) K200070 Active Cleared 23 Apr 2020 GUDID on market

• Arx 13-6550-13

  Class II

  FDA 510(k) K200070 Active Cleared 23 Apr 2020 GUDID on market

• Arx 13-5545-13

  Class II

  FDA 510(k) K200070 Active Cleared 23 Apr 2020 GUDID on market

• Arx 13-5540-13

  Class II

  FDA 510(k) K200070 Active Cleared 23 Apr 2020 GUDID on market

• Arx 13-6545-13

  Class II

  FDA 510(k) K200070 Active Cleared 23 Apr 2020 GUDID on market

See all devices from Life Spine, Inc. →

• What types of surgical approaches is the 2 Hole Lateral Plating System designed for, and why is this important for clinicians?

  The 2 Hole Lateral Plating System is specifically designed for use via a lateral or anterolateral approach to the lumbar spine. This distinction is important because it ensures compatibility with minimally invasive techniques that avoid direct pedicle access, reducing soft tissue trauma and potentially shortening recovery times. The system’s rigid two-hole screw-plate construct provides segmental control, making it suitable for supplemental fixation in spinal stabilization procedures where lateral positioning is preferred.

• Is the 2 Hole Lateral Plating System intended for reuse, and if not, how should it be handled after use to ensure patient safety?

  No, the 2 Hole Lateral Plating System is explicitly intended for single-use only. Since it is supplied sterile, it must be treated as a single-patient device to prevent cross-contamination. After use, it should be disposed of according to standard medical device waste protocols for orthopedic hardware, ensuring compliance with infection control guidelines and regulatory requirements.

• What are the key differences between this system and traditional pedicle screw fixation, and how does that affect its clinical application?

  Unlike traditional pedicle screw fixation, the 2 Hole Lateral Plating System is a non-pedicle device, meaning it bypasses the posterior elements of the spine entirely. This design allows for lateral or anterolateral placement, which can be advantageous in cases where pedicle access is challenging or contraindicated. The system’s rigid two-hole plate configuration provides supplemental fixation specifically for segmental control in the lumbar spine, often used in conjunction with other stabilization techniques to enhance stability without the need for posterior instrumentation.

• How should the 2 Hole Lateral Plating System be stored to maintain its sterility and functionality before use?

  Since the system is supplied sterile, it should be stored in its original, unopened packaging in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. The packaging should remain intact until immediately before use to preserve sterility. Follow the manufacturer’s specific storage instructions, which may include keeping the device in a sealed pouch or container as specified in the accompanying documentation.

• What does the FDA 510(k) clearance (K172131) indicate about the intended use and regulatory pathway of this device?

  The FDA 510(k) clearance (K172131) confirms that the 2 Hole Lateral Plating System is classified as substantially equivalent to a predicate device under the Orthopedic advisory committee (OR). This means it has been evaluated and determined to have the same intended use and technological characteristics as a previously cleared device, specifically for spinal stabilization via a lateral or anterolateral approach in the lumbar spine. The clearance does not imply any specific clinical indication but rather confirms regulatory compliance with the FDA’s requirements for orthopedic fixation devices.