# K051942: Malibu Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Jul 27, 2005 after 12 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K901587 (1990). 27 ancestors in all.
81 later devices descend from it; 9 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1.
- K002607: Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral Extenders, Depuyacromed (2000) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K993503: Haider-Ucr Spinal System, International Advanced Medical Enterprises, Inc. (2000) Summary page 1.
- K021623: Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments, Iame, Inc. (2002) Summary page 1.
- K031381: Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments, Seaspine (2003) Summary page 1.
- K032739: Ucr Spinal System, Seaspine (2003) Summary page 1.
- K043232: Ucr Spinal System, Seaspine (2004) Summary page 1.

## Most influential descendants
- K061342: Malibu Spinal System (2006), 80 descendants of its own
- K072605: Malibu Spinal System (2007), 67 descendants of its own
- K122571: Malibu Spinal System with the Daytona Deformity System (2012), 62 descendants of its own
- K160902: Mariner Pedicle Screw System (2016), 60 descendants of its own
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own

## Recalls of this device
- Jan 22, 2014 · Class II · Z-0938-2014: 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 rep
- Mar 4, 2009 · Not classified · Z-1927-2009: 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.
- Mar 4, 2009 · Not classified · Z-1926-2009: 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.
- Mar 4, 2009 · Not classified · Z-1925-2009: 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.
- Mar 4, 2009 · Not classified · Z-1921-2009: 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.
- Mar 4, 2009 · Not classified · Z-1920-2009: 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.
- Mar 4, 2009 · Not classified · Z-1919-2009: 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.
- Mar 4, 2009 · Not classified · Z-1918-2009: 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.
- Mar 4, 2009 · Not classified · Z-1922-2009: 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.
- Mar 4, 2009 · Not classified · Z-1923-2009: 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.
- Mar 4, 2009 · Not classified · Z-1924-2009: 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.

## Indications for use
The intended use of the Malibu Spinal System, polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: * degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, * severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System), * spondylolisthesis, * trauma (i.e., fracture or dislocation), * spinal stenosis, * deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * spinal tumor, * pseudoarthrosis, and/or failed previous fusion. The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: * degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, * spondylolisthesis * trauma (i.e., fracture or dislocation), * spinal stenosis, * deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), * tumor, * pseudarthosis, and/or * failed previous fusion.

Source page: https://510kreport.com/device/K051942
Methodology: https://510kreport.com/methodology