# K133690: True Spinal Fussion System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Surgical Designs
- Decided: May 7, 2014 after 156 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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
Longest line of descent: 5 generations back to K901587 (1990). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 1.
- K041460: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2004) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 1.
- K130958: True Spinal Fixation System, Innovative Surgical Designs (2013) Summary page 1.

## Indications for use
The Truetm Spinal Fixation System is intended for posterior, noncervical (Ti-Si) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K133690
Methodology: https://510kreport.com/methodology