# K032398: Plus Pivot Link Universal System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Oct 31, 2003 after 88 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.
No later device cites it as a predicate yet.
0 of 1 device 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) AcroMed: named in the summary without a submission number

## Indications for use
When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUSTM 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 firsion (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-SI vertebra; receive firsions 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 hsion (pseudoarthrosis)

Source page: https://510kreport.com/device/K032398
Methodology: https://510kreport.com/methodology