Malibu Spinal System

• • Terminated Z-0938-2014 FDA Class II ·initiated 22 Jan 2014

  Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.

510(k) Number

K061342 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Sierra

  Class II

  FDA 510(k) K062934 Active Cleared 16 Nov 2006

• Ucr Spinal System

  Class II

  FDA 510(k) K032739 Active Cleared 20 Nov 2003

• Cardiff Anterior Cervical Plate System

  Class II

  FDA 510(k) K083338 Active Cleared 2 Feb 2009

• Hollywood, Pacifica, Redondo, Ventura

  Class II

  FDA 510(k) K082310 Active Cleared 10 Nov 2008

• Zuma, Model 55-Xxxx/56-Xxxx

  Class II

  FDA 510(k) K082926 Active Cleared 22 Dec 2008

• Newport Spinal System

  Class II

  FDA 510(k) K083089 Active Cleared 13 Jan 2009

See all devices from Seaspine, Inc. →

• What types of spinal surgeries is the Malibu Spinal System designed for, and how does its design support those procedures?

  The Malibu Spinal System is specifically designed for thoracolumbar and sacral fusion procedures, which involve stabilizing the spine in the lower back and pelvic region. Its components—pedicle screws, rods, and integrated locking caps—are engineered for secure fixation, ensuring precise alignment and stability during spinal surgeries. The system’s modular design allows for versatile configurations tailored to these spinal segments, making it suitable for orthopedic interventions requiring robust stabilization.

• Is the Malibu Spinal System intended for reuse, or is it meant to be used only once? How should it be stored to maintain sterility?

  The Malibu Spinal System is explicitly intended for single-use only. To preserve sterility, it must be stored within its original sterile packaging until the time of surgical use. Adhering to sterile packaging protocols is critical to maintaining the device’s integrity and preventing contamination before implantation.

• What size options are available for the pedicle screws and rods in this system, and are they standardized for adult spinal applications?

  The Malibu Spinal System offers standardized sizes for adult spinal applications, with configurations specifically tailored for thoracolumbar and sacral segments. While exact measurements aren’t detailed here, the design emphasizes compatibility between screws and rods to ensure precise alignment and secure fixation during surgery. Sizing is optimized for these anatomical regions to facilitate effective spinal stabilization.

• How is the Malibu Spinal System regulated in the U.S., and what does its FDA clearance status indicate about its safety and effectiveness?

  The Malibu Spinal System holds FDA 510(k) clearance (K061342), classified as substantially equivalent to a predicate orthopedic device under the Traditional review pathway. This clearance indicates that the FDA has determined the device meets regulatory standards for safety and performance comparable to existing, legally marketed alternatives. The clearance does not imply approval for specific clinical indications but confirms compliance with U.S. regulatory requirements for spinal fixation devices.

• Can the Malibu Spinal System be used in patients who require MRI scans after surgery, or are there any known restrictions?

  The available data does not specify an MRI safety classification for the Malibu Spinal System. This means there is no confirmed information on whether its components are MRI-compatible or pose risks during imaging. Clinicians should consult the manufacturer’s updated labeling or technical documentation before using the device in patients who require MRI scans post-surgery, as non-MRI-safe materials could cause heating or artifacts.