# K140219: Picasso II Mis Spinal System

- Pathway: 510(k) (Special)
- Applicant: Accel Spine
- Decided: Apr 14, 2014 after 75 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: 10 generations back to K950697 (1995). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120714: Picasso Mis Spinal Fixation System, Accel Spine (2012) Summary page 1.
- K132365: Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation, Accel Spine (2013) Summary page 1.

## Most influential descendants
- K173185: SEURAT™ Universal Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
The Picasso 11 MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso 11 MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso 11 MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis. and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous approach with MIS Instrumentation, the Picasso 11MIS Spinal System is intended for noncervical pedlicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis. and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K140219
Methodology: https://510kreport.com/methodology