# K180754: C-Zero Pedicle Screw System, Freedom Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Dec 7, 2018 after 260 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: 14 generations back to K990745 (1999). 190 ancestors in all.
No later device cites it as a predicate yet.
1 of 191 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081252: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 4.
- K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 4.
- K023644: Modification to Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 4.
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 4.
- K150184: Dymaxeon Spine System, Back 2 Basics Direct, LLC (2015) Summary page 4.

## Indications for use
The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are 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 and deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; and failed previous fusion (pseudarthrosis). In addition, the C-Zero Pedicle Screw and Freedom Pedicle Systems are intended for skeletally mature patients in the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.

Source page: https://510kreport.com/device/K180754
Methodology: https://510kreport.com/methodology