# K112759: Apclo Pedicle Screw Systems

- Pathway: 510(k) (Special)
- Applicant: Atlas Spine, Inc.
- Decided: Oct 18, 2011 after 26 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: 9 generations back to K950697 (1995). 42 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072426: Atlas Spine Pedicle Screw System, Atlas Spine, LLC (2007) Summary page 1.
- K110842: Atlas Spine Pedicle Screw System, Atlas Spine, Inc. (2011)
- K041592: Coral Spinal System, Theken Surgical (2004) Summary page 1.
- K081414: Modification to Coral Spinal System, Theken Spine, LLC (2008) Summary page 1.

## Most influential descendants
- 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

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

Source page: https://510kreport.com/device/K112759
Methodology: https://510kreport.com/methodology