# K152277: PIVOX (tm) Oblique Lateral Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 13, 2015 after 93 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: 16 generations back to K003155 (2001). 192 ancestors in all.
190 later devices descend from it; 4 cite it directly.
1 of 383 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K133577: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K131669: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5.
- K071416: Pyramid +4 Anterior Lumbar Spine Plate System, Medtronic Sofamor Danek USA, Inc. (2007) Summary page 5.
- K991460: Modification to Zplate-Atl Anterior Fixation System, Sofamor Danek (1999) Summary page 5.
- K091442: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 5.

## Most influential descendants
- 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
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System (2020), 60 descendants of its own

## Indications for use
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. 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. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be 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 PIVOX™ Oblique Lateral Spinal System components can be used to treat 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.

Source page: https://510kreport.com/device/K152277
Methodology: https://510kreport.com/methodology