# K992147: Triple-Fix Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Spine Technology, Inc.
- Decided: Feb 28, 2000 after 249 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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
No predicates in its family tree.
451 later devices descend from it; 3 cite it directly.
0 of 452 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Isola Spinal System: named in the summary without a submission number
- (no number) Mirage Spinal System: named in the summary without a submission number

## Most influential descendants
- K001668: Global Spinal Fixation System (2000), 450 descendants of its own
- K053573: GSS Pedicle Screw System (2006), 181 descendants of its own
- K033090: Icon Polyaxial Pedicle Screw System (2004), 180 descendants of its own
- K062513: Apex Spine System (2006), 179 descendants of its own
- K031455: Conklusion Pedicle Screw System (2003), 179 descendants of its own

## Indications for use
The Triple-Fix Spinal System is a pedicle screw system intended 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: degenerative spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The posterior Triple-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The posterior Triple-Fix System, when not used with pedicle screws is indicated for hook, wire, and /or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

Source page: https://510kreport.com/device/K992147
Methodology: https://510kreport.com/methodology