# K231799: INERTIA® CONNEXX™ Modular Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Nexxt Spine, LLC
- Decided: Jul 20, 2023 after 30 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: 22 generations back to K040583 (2004). 626 ancestors in all.
No later device cites it as a predicate yet.
0 of 627 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153453: Inertia Pedicle Screw and Deformity Correxxion System, Nexxt Spine, LLC (2016) Summary page 5.
- K223273: ASTRA Spine System, Spinecraft, LLC (2022) Summary page 5.
- K090984: Inertia Pedicle Screw System, Nexxt Spine, LLC (2009) Summary page 5.
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010) Summary page 5.
- K132412: Inertia Mis Pedicle Screw System, Nexxt Spine, LLC (2013) Summary page 5.
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws, Nexxt Spine, LLC (2014) Summary page 5.
- K221905: INERTIA CONNEXX Modular Pedicle Screw System, Nexxt Spine, LLC (2022) Summary page 5.

## Indications for use
The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K231799
Methodology: https://510kreport.com/methodology