# K141282: PGS 5.5 MM Cannulated Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Pinnacle Spine Group
- Decided: Dec 2, 2014 after 200 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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 K901587 (1990). 85 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 6.
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 6.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 6.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 6.
- K081080: TSRH Spinal System, Medtronic Sofamor Danek (2008) Summary page 6.
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 6.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 6.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 6.
- K102870: Exactech Proliant Polyaxial Pedicle Screw System, Exactech, Inc. (2011) Summary page 6.

## Most influential descendants
- K191655: MEGAFIX® Pedicle Screw Spinal System (2020), 0 descendants of its own

## Indications for use
The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion. The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

Source page: https://510kreport.com/device/K141282
Methodology: https://510kreport.com/methodology