# K122571: Malibu Spinal System with the Daytona Deformity System

- Pathway: 510(k) (Special)
- Applicant: Seaspine, Inc.
- Decided: Dec 12, 2012 after 111 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: 11 generations back to K901587 (1990). 54 ancestors in all.
62 later devices descend from it; 6 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072605: Malibu Spinal System, Seaspine, Inc. (2007) Summary page 1.
- 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.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K021623: Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments, Iame, Inc. (2002) Summary page 1.
- K053276: Ist Pedicle Screw System, Innovative Spinal Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own
- K211606: Mariner Deformity System (2021), 47 descendants of its own
- K212692: Mariner Pedicle Screw System (2021), 46 descendants of its own
- K220195: iFuse Bedrock Granite™ Implant System (2022), 32 descendants of its own
- K222774: iFuse Bedrock Granite® Implant System (2022), 20 descendants of its own

## Indications for use
The intended use of the Malibu System when used as a Pedlicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, isto 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 (ODD) 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 LS-Si vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine ([ _3 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 (ihe., fracture or dislocation), -spinalstenosis, -deformities or curvatures (ihe., scoliosis, kyphosis, and/or lordosis), -spinaltumor, -pseudoarthrosis, and/or -failed previous fusion. The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthasis or Hook Spinal System, are limited to Ti-I_5 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 (he., fracture or dislocation), - spinal stenosis, - deformities or curvatures (ihe., scoliosis, kyphosis, and/or lordosis), - tumor, - pseudarthosis, and/or - failed previous fusion.

Source page: https://510kreport.com/device/K122571
Methodology: https://510kreport.com/methodology