# K130302: Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle Screw Fixat

- Pathway: 510(k) (Special)
- Applicant: Spinevision S.A.
- Decided: Jul 30, 2013 after 173 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 11 generations back to K990745 (1999). 41 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 46 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.

## Most influential descendants
- K133575: Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System (2014), 3 descendants of its own
- 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. TM and LUMIS' M 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 * tumors * failed previous fusion (pseudoarthrosis) The U.L.I.S. m and LU MIS TM systems are pedicle screw systems indicated for skeletally mature patients who: * have severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebra; * receive fusions using autogenous bone graft only; * have the device fixed or attached to the lumbar and sacral spine (L-3 to sacrum); and * have the device removed after the development of a solid fusion. In addition, the U.L. I.S. Th' and LUMIS' M 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 (TiC-Si): * degenerative spondylolisthesis with objective evidence of neurologic impairment * fracture * spinal tumor * failed previous fusion (pseudoarthrosis)

Source page: https://510kreport.com/device/K130302
Methodology: https://510kreport.com/methodology