# K153453: Inertia Pedicle Screw and Deformity Correxxion System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Apr 26, 2016 after 148 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: 16 generations back to K853033 (1985). 344 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152457: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K133369: Tiger Spine System, Corelink, LLC (2014) 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.

## Most influential descendants
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own
- K223413: Pisces™-SA STANDALONE ALIF Interbody System (2023), 3 descendants of its own

## Indications for use
The Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for pedicle and non-pedicle 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® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Inertia® Pedicle Screw and Deformity Correxxion™ 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/K153453
Methodology: https://510kreport.com/methodology