# K140678: Cosmolock Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: Jun 19, 2014 after 93 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: 7 generations back to K000319 (2000). 84 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033090: Icon Polyaxial Pedicle Screw System, Alphatec Mfg., Inc. (2004) Summary page 1.
- K042673: Zodiac Polyaxial Spinal Fixation System, Alphatec/Nexmed (2004) Summary page 1.
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2007) Summary page 1.
- K093077: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2009) Summary page 1.
- K100685: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2010) Summary page 1.
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.
- K052761: Modification to:  Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 1.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K060748: Modification to Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 1.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 1.
- K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K920116: PWB Lumbosacral Spine System, Cross Medical Products, Inc. (1992) Summary page 1.

## Most influential descendants
- K163471: Kalitec Direct InSePtion™ MIS Fixation System (2017), 6 descendants of its own
- K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (2018), 5 descendants of its own
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (2018), 4 descendants of its own
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own
- K172808: CosmoLock Pedicle Screw System (2017), 2 descendants of its own

## Indications for use
The CosmoLock Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the LS-S I vertebra in skeletally mature patients receiving fusion 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, ktyphosis, and/or lordosis), tumor pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K140678
Methodology: https://510kreport.com/methodology