# K120270: Venus Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Mar 26, 2012 after 56 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: 10 generations back to K990745 (1999). 113 ancestors in all.
111 later devices descend from it; 9 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100706: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2010) Summary page 1.
- K103085: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 1.
- K091717: Any Plus Spinal Fixation System, GS Medical Co., Ltd. (2010) Summary page 1.
- K062513: Apex Spine System, Spinecraft, Inc. (2006) Summary page 1.
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer, Spinecraft, Inc. (2010) Summary page 1.
- K102488: Apex Spine System W/ Cocr Rods, Spinecraft, LLC (2010) Summary page 1.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007)
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 1.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009) Summary page 1.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1.

## Most influential descendants
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143363: VENUS Spinal Fixation System (2015), 33 descendants of its own
- K171813: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System (2017), 30 descendants of its own

## Indications for use
VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: * degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); * spondylolisthesis; * trauma (i.e., fracture or dislocation); * deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); * tumor; * stenosis, and * failed previous fusion (pseudoarthrosis) The VENUS Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 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. In addition, the VENUS Spinal Fixation 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K120270
Methodology: https://510kreport.com/methodology