# K133575: Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinevision S.A.
- Decided: Jun 30, 2014 after 222 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: 13 generations back to K853033 (1985). 206 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112607: Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S.(TM) Polyaxial Pedicle ..., Spinevision S.A. (2012) Summary page 1.
- K130302: Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle Screw Fixat, Spinevision S.A. (2013) Summary page 1.
- K013301: Uni-T Spinal System, Spine Vision, Inc. (2002) Summary page 1.
- K062912: Scient'x Spinal System, Scient'X (2007) 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.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K111571: Viper Systems, Johnson & Johnson (2011)
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.
- K102701: Viper Spine System, Depuy Spine, Inc. (2010) Summary page 1.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009)
- K090799: Modification to Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2007) Summary page 1.

## Most influential descendants
- K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (2016), 2 descendants of its own
- K200267: LOSPA® IS™ Spinal Fixation System (2020), 1 descendant of its own
- K240180: Orthopeasia Spinal Fixation System (2024), 0 descendants of its own

## Indications for use
When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S. and LUMIS systems are indicated for: * degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * fracture * spinal stenosis * curvatures (i.e. scoliosis, kyphosis, and/or lordosis) * tumors * failed previous fusion (pseudoarthrosis) The U.L.I.S. and LUMIS systems are pedicle screw systems indicated for skeletally mature patients who: * have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; * receive fusions using autogenous bone graft only; * have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and * have the device removed after the development of a solid fusion. In addition, the U.L.I.S. and LUMIS systems are pedicle screw systems 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 (TIO0-Slj): * degenerative spondylolisthesis with objective evidence of neurologic impairment * fracture * curvatures (i.e. scoliosis, kyphosis, and/or lordosis) * spinal tumor * failed previous fusion (pseudoarthrosis)

Source page: https://510kreport.com/device/K133575
Methodology: https://510kreport.com/methodology