# K132412: Inertia Mis Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Nexxt Spine, LLC
- Decided: Oct 10, 2013 after 69 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 5 generations back to K901587 (1990). 34 ancestors in all.
107 later devices descend from it; 4 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010) Summary page 1.
- K090984: Inertia Pedicle Screw System, Nexxt Spine, LLC (2009) Summary page 1.

## Most influential descendants
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own

## Indications for use
The lnertiaTM MIS Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (Ti to S2): severe spondylolisthesis (grades 3 and 4) of the L-5-Sl vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture: dislocation; spinal stenosis; scoliosis; kyphosis; spinal rumor, and failed previous fusion (pseudartbrosis).

Source page: https://510kreport.com/device/K132412
Methodology: https://510kreport.com/methodology