# K133340: Spineworks Anterior Lumbar Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineworks, LLC
- Decided: Apr 11, 2014 after 163 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: 15 generations back to K841189 (1984). 81 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111166: A-Wedge Anterior Interbody System (a-Wedge a.I.S.), Spineworks, LLC (2011) Summary page 1.
- K121693: A-Wedge Anterior Interbody System (a-Wedge Ais), Sapphire Medical Group, Inc. (2012) Summary page 1.
- K123969: Xiphos, Difusion Technologies (2013) Summary page 1.

## Most influential descendants
- K153123: Genesys Spine Apache Interbody Fusion System (2016), 12 descendants of its own
- K161438: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (2016), 11 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K211417: F3D-C2 Cervical Stand-Alone System (2022), 3 descendants of its own

## Indications for use
The SpineWorks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SpineWorks Anterior Lumbar Devices are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SpineWorks Anterior Lumbar Devices are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K133340
Methodology: https://510kreport.com/methodology