# K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 11, 2015 after 141 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 K003155 (2001). 155 ancestors in all.
228 later devices descend from it; 11 cite it directly.
1 of 384 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131669: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5.
- K133650: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 6.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 6.
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst, Medtronic Sofamor Danek, Inc. (2013) Summary page 6.
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 6.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 6.
- K071416: Pyramid +4 Anterior Lumbar Spine Plate System, Medtronic Sofamor Danek USA, Inc. (2007) Summary page 6.
- K991460: Modification to Zplate-Atl Anterior Fixation System, Sofamor Danek (1999) Summary page 6.

## Most influential descendants
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 descendants of its own
- K161379: ELSA Spacers (2016), 155 descendants of its own
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device (2016), 79 descendants of its own
- K173260: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System (2017), 67 descendants of its own
- K181079: SeaSpine Regatta Lateral System (2018), 63 descendants of its own

## Indications for use
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody is indicated for interbody fusion in patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion Interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Interbody cages with a lordosis of 18º or greater must be used with at least supplemental, anterior fixation. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. When used together, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System components can be used only to treat patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.

Source page: https://510kreport.com/device/K150135
Methodology: https://510kreport.com/methodology