# K143230: Palladian Lumbar Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Feb 25, 2015 after 107 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.
No later device cites it as a predicate yet.
0 of 86 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 5.
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 5.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 5.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 5.
- K081080: TSRH Spinal System, Medtronic Sofamor Danek (2008) Summary page 5.
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 5.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 5.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 5.
- K102870: Exactech Proliant Polyaxial Pedicle Screw System, Exactech, Inc. (2011) Summary page 5.

## Indications for use
The use of the Palladian™ Lumbar Pedicle Screw System is indicated as an adjunct to fusion of the L5-S1 vertebra for the treatment of; 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 Palladian™ Lumbar Pedicle Screw System is a non-cervical spinal fixation system, and intended for use with autograft and/or allograft. Pedicle screw fixation is limited to skeletally mature patients.

Source page: https://510kreport.com/device/K143230
Methodology: https://510kreport.com/methodology