# K111301: Instinct Java System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine
- Decided: Aug 26, 2011 after 109 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901587 (1990). 29 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310), Abbott Spine, Inc. (2008) Summary page 1.
- K042702: Silhouette Spinal Fixation System, Zimmer Spine, Inc. (2004) Summary page 1.
- K100377: Diamondback Spinal System, Eminent Spine (2010) Summary page 1.

## Most influential descendants
- K113270: Instinct Java System (2011), 2 descendants of its own
- K123552: Instinct Java System (2013), 0 descendants of its own
- K122592: Instinct Java System (2013), 0 descendants of its own

## Recalls of this device
- Feb 12, 2016 · Class II · Z-1190-2016: Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universa

## Indications for use
The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kylphotic or lordotic spinal deformities, scoliosis, tumor and pseudloarthrosis, or for revision of a failed previous fusion.

Source page: https://510kreport.com/device/K111301
Methodology: https://510kreport.com/methodology