# K113346: Neon System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Feb 28, 2012 after 106 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003155 (2001). 90 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033980: Blackstone Ascent Poct System Hooks (System Modification), Blackstone Medical, Inc. (2004). Our reading of the summary gave K033480, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ascent POCT System”.
- K073420: Blackstone Ascent Multiaxial Screws, Blackstone Medical, Inc. (2008) Summary page 2.
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System, Spinal Concepts, Inc. (2003) Summary page 2.
- K052566: Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120.  Nex-Link Spinal Fixation SY, Abbott Spine, Inc. (2006) Summary page 2.
- K062505: Nex-Link Spinal Fixation System Offset Connectors, 2121-XX Series, Abbott Spine, Inc. (2006) Summary page 2.
- K090060: Nexlink Oct System, Model 7000 Series, Abbott Spine, Inc. (2009) Summary page 2.
- K030377: Modification to Synthes Cervifix System, Synthes (Usa) (2003) Summary page 2.
- K011969: Synthes Cervifix System, Synthes (Usa) (2001). Our reading of the summary gave K011966, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CerviFix System”.

## Most influential descendants
- K230614: Cortium™ (2023), 0 descendants of its own

## Indications for use
When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon m are indicated for the treatment of: * DDID (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), * spondylolisthesis, * spinal stenosis, * fracture/dislocation, * atlantoaxial fracture with instability, * occipitocervical dislocation, * revision of previous cervical spine surgery, and * tumors The cortical (3.5mm) bone screws are limited to occipital fixation only. The.- hook, rod and crosslink component. placement is indicated for the cervical/upper thoracic (CI-T3) spine. The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K113346
Methodology: https://510kreport.com/methodology