# K123552: Instinct Java System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine
- Decided: Apr 19, 2013 after 151 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: 7 generations back to K992147 (2000). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111301: Instinct Java System, Zimmer Spine (2011)
- K113270: Instinct Java System, Zimmer Spine (2011) Summary page 1.
- K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310), Abbott Spine, Inc. (2008) Summary page 1.
- K100297: Pass LP Spinal System, Medicrea Technologies (2010) Summary page 1.
- K121764: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2012) Summary page 1.

## 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, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudloarthrosis, or for revision of a failed previous fusion.

Source page: https://510kreport.com/device/K123552
Methodology: https://510kreport.com/methodology