# K071743: Pillar Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: The 4th Column, LLC
- Decided: Jul 6, 2007 after 9 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: 3 generations back to K951116 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982511: Depuy Motech Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 2.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 2.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 2.

## Cited in the summary but kept off the family tree
- K001585: Biocurve Soft (Methafilcon a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear & Blue Visibility Tint, Lathe, American Biocurve, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. The Pillar Pedicle Screw System also 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K071743
Methodology: https://510kreport.com/methodology