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Malibu Spinal System

by Seaspine, Inc. 4 variants

510(k) K051942

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051942 Date27 Jul 2005ClearedStatusActive

Recalls

11 recalls · FDA

    • Terminated Z-0938-2014 FDA Class II initiated 22 Jan 2014 on shared 510(k) K051942

    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.

  • 10 recalls, same reason

    • Terminated Z-1922-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1927-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1926-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1924-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1925-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1918-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1920-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1923-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1921-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009
    • Terminated Z-1919-2009 FDA Unclassified (pre-2012) initiated 4 Mar 2009

    SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Malibu Spinal System is a thoracolumbar screws/rods system designed for spinal fixation. It is a pedicle screw system that includes integrated locking caps, threaded screws, and rods for spinal stabilization.

The system is offered in a variety of lengths to accommodate variations in patient anatomy and is manufactured from titanium. It received FDA 510(k) clearance (K051942) as substantially equivalent to a predicate device, with product code KWP and advisory committee classification in orthopedics (OR).

Other devices from Seaspine, Inc.

See all devices from Seaspine, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Malibu Spinal System used for?

    The Malibu Spinal System is designed for spinal fixation in the thoracolumbar region, providing stabilization through pedicle screws, rods, and integrated locking caps to immobilize vertebral segments during fusion procedures.

  • How is the Malibu Spinal System supplied and what materials is it made from?

    The system is supplied as a set of titanium components including pedicle screws, rods, and integrated locking caps, manufactured from titanium to accommodate variations in patient anatomy through a range of screw and rod lengths.

  • Is the Malibu Spinal System intended for single-use or reuse?

    The Malibu Spinal System is intended for single-use implantation; its components are designed to be implanted permanently as part of a spinal fusion construct and are not approved for reprocessing or reuse after removal.