# K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA
- Decided: Oct 20, 2023 after 122 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K040583 (2004). 557 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 559 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200596: G21 Cement, VADER® Pedicle System, Icotec AG (2020) Summary page 6.
- K191932: Momentum™ Posterior Spinal Fixation System, Ulrich Medical USA (2019) Summary page 6.
- K222256: BonOs® Inject Bone Cement; NEO Pedicle Screw System™, Neo Medical SA (2022) Summary page 6.
- K223274: Momentum® MIS Posterior Spinal Fixation System, Ulrich Medical USA (2022) Summary page 6.

## Most influential descendants
- 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. When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement. 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. The Momentum® MIS 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 MIS 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. When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior Spinal Fixation System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum MIS Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

Source page: https://510kreport.com/device/K231809
Methodology: https://510kreport.com/methodology