# K100743: Atlas Spine Pivoting System

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, Inc.
- Decided: Aug 10, 2010 after 147 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010530 (2001). 14 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 1.
- K091406: Atlas Spine Spacer, Atlas Spine, LLC (2009)
- K092017: Pivotec Lumbar Interbody Fusion Device (Lifd), Captiva Spine, Inc. (2009) Summary page 1.

## Most influential descendants
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K243816: Testa TP Pivoting Spacer System (2025), 0 descendants of its own
- K183243: Velofix TLIF Cage (2019), 0 descendants of its own

## Indications for use
The Atlas Spine Pivoting System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.

Source page: https://510kreport.com/device/K100743
Methodology: https://510kreport.com/methodology