# K101278: Inertia Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Nexxt Spine, LLC
- Decided: Dec 20, 2010 after 228 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 4 generations back to K901587 (1990). 32 ancestors in all.
111 later devices descend from it; 7 cite it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 1.
- K041460: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2004) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 1.

## Most influential descendants
- K132412: Inertia Mis Pedicle Screw System (2013), 107 descendants of its own
- 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

## Indications for use
The Inertia 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 L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoiosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K101278
Methodology: https://510kreport.com/methodology