# K072605: Malibu Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Dec 20, 2007 after 94 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K901587 (1990). 52 ancestors in all.
67 later devices descend from it; 7 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061342: Malibu Spinal System, Seaspine, Inc. (2006) Summary page 1.
- K051942: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 1.
- K051663: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 1.
- K020426: MSD Wire System, Medtronic Sofamor Danek, Inc. (2002)
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.

## Most influential descendants
- 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
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own
- K211606: Mariner Deformity System (2021), 47 descendants of its own

## Indications for use
1. The intended use of the Malibu 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-SI 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. 2. The intended use and indications of the Malibu system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System or Sublaminar Wire System, are limited to T1I-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, * spondylolisthiesis, * trauma (ie., fracture or dislocation), * spinal stenosis, * deformities or curvatures (iLe., scoliosis, kyphosis, and/or lordosis), * tumor, * pseudarthosis, and/or * failed previous fusion.

Source page: https://510kreport.com/device/K072605
Methodology: https://510kreport.com/methodology