# K161032: neon3™  universal OCT spinal stabilization

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Dec 22, 2016 after 253 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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: 13 generations back to K003155 (2001). 92 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 6.
- K962314: Halifax Plus Interlaminar Clamp System, Osteonics Corp. (1996) Summary page 6.
- K150650: neon3, Ulrich GmbH & Co. KG (2015) Summary page 6.
- 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 6.

## Most influential descendants
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 descendants of its own
- K221307: Edge Upper Cervical System (2023), 0 descendants of its own
- K230614: Cortium™ (2023), 0 descendants of its own

## Recalls of this device
- Mar 8, 2019 · Class II · Z-1126-2019: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

## Indications for use
neon3™ is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. neon3™ is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K161032
Methodology: https://510kreport.com/methodology