# K221905: INERTIA CONNEXX Modular Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Nexxt Spine, LLC
- Decided: Jul 28, 2022 after 28 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: 19 generations back to K853033 (1985). 467 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 469 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 4.
- K143334: Range/Denali/Mesa Spinal System, K2m, Inc. (2015) Summary page 4.
- K152457: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K090984: Inertia Pedicle Screw System, Nexxt Spine, LLC (2009) Summary page 4.
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010) Summary page 4.
- K132412: Inertia Mis Pedicle Screw System, Nexxt Spine, LLC (2013) Summary page 4.
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws, Nexxt Spine, LLC (2014) Summary page 4.

## Most influential descendants
- K231799: INERTIA® CONNEXX™ Modular Pedicle Screw System (2023), 0 descendants of its own

## Indications for use
The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (Tl-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 adolescent idiopathic scoliosis. 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/K221905
Methodology: https://510kreport.com/methodology