# K191932: Momentum™ Posterior Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA
- Decided: Oct 2, 2019 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: 16 generations back to K853033 (1985). 402 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 405 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123717: Ucentum, Ulrich GmbH & Co. KG (2013) Summary page 4.
- K133369: Tiger Spine System, Corelink, LLC (2014) Summary page 4.
- K102853: Flamenco Spinal Fixation System, Ulrich GmbH & Co. KG (2011) Summary page 4.
- K161032: neon3™  universal OCT spinal stabilization, Ulrich GmbH & Co. KG (2016) Summary page 4.
- K151704: Diplomat® Spinal System, Signus Medizintechnik GmbH (2016) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion. In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

Source page: https://510kreport.com/device/K191932
Methodology: https://510kreport.com/methodology