# K191726: mont blanc & mont blanc MIS Spinal Systems

- Pathway: 510(k) (Traditional)
- Applicant: Spineway SA
- Decided: Sep 12, 2019 after 77 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: 15 generations back to K853033 (1985). 101 ancestors in all.
No later device cites it as a predicate yet.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems, Spineway SA (2016) Summary page 6.
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 7.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 7.

## Indications for use
The mont blanc 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/iliac spine. This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation from T1 to S1 for the following indications in skeletally mature patients: • 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; • deformities (i.e., scoliosis, kyphosis, and/or lordosis); • spinal tumor, • pseudoarthrosis; and • failed previous fusion. The mont blanc system is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The mont blanc MIS 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. This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients: • 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; • deformities (i.e., scoliosis, kyphosis, and/or lordosis); • spinal tumor, • pseudoarthrosis; and • failed previous fusion. The mont blanc MIS system is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K191726
Methodology: https://510kreport.com/methodology