# K033508: Plus Pivot Link Universal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Jan 27, 2004 after 82 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PLUS Pivot Link Spinal System: named in the summary without a submission number
- (no number) MOSS Miami Spinal System: named in the summary without a submission number
- (no number) Universal Spine System: named in the summary without a submission number

## Most influential descendants
- K112607: Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S.(TM) Polyaxial Pedicle ... (2012), 5 descendants of its own
- K130302: Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle Screw Fixat (2013), 4 descendants of its own
- 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

## Indications for use
When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS TM Pivot Link Universal System is indicated for: * degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * fracture * spinal stenosis * deformities (i.e. scoliosis, kyphosis, lordosis) * tumors * failed previous fusion (pseudoarthrosis) The PLUS Pivot Link Universal System is also a pedicle screw system 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 PLUS Pivot Link Universal System is a pedicle screw system 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 neurologic impairment * fracture * dislocation * scoliosis * kyphosis * spinal tumor * failed previous fusion (pseudoarthrosis)

Source page: https://510kreport.com/device/K033508
Methodology: https://510kreport.com/methodology