# K253249: TriALTIS™ Spine System

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Oct 21, 2025 after 22 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: 21 generations back to K040583 (2004). 234 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 236 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231479: TriALTIS Spine System, Medos International SARL (2023) Summary page 5.
- K200245: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System, Medos International Sàrl (2020) Summary page 5.
- K233684: TriALTIS™ Spine System, Medos International SARL (2023) Summary page 5.

## Most influential descendants
- K253943: Tiger 2 System (2026), 0 descendants of its own

## Indications for use
The TriALTIST r Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The TriALTIST r Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1- S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation in pediatric patients, the TriALTIST r Spine System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e, scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the TriALTISTM Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTISTMr Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When the TriALTIST-r Spine System fenestrated screws are used in conjunction with CONFIDENCE TM High Viscosity Spinal Cement, the TriALTIS T M Spine System is intended to stabilize 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. The TriALTIST-r fenestrated screws augmented with the CONFIDENCE TM High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K253249
Methodology: https://510kreport.com/methodology