# K072426: Atlas Spine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, LLC
- Decided: Oct 19, 2007 after 51 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K950697 (1995). 23 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010515: Modification to Synergy Spinal System, Interpore Cross Intl. (2001) Summary page 1.
- K010742: Moss Miami 5.5MM Titanium Pin Nut, Depuyacromed (2001) Summary page 1.
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 1.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.

## Most influential descendants
- K110842: Atlas Spine Pedicle Screw System (2011), 4 descendants of its own
- K112759: Apclo Pedicle Screw Systems (2011), 2 descendants of its own
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (2025), 1 descendant of its own
- K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (2026), 0 descendants of its own
- K111634: Xenon (TM) Pedicle Screw System (2012), 0 descendants of its own

## Recalls of this device
- Jun 4, 2009 · Class II · Z-2274-2012: Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fracture

## Indications for use
The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation 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, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K072426
Methodology: https://510kreport.com/methodology