# K071416: Pyramid +4 Anterior Lumbar Spine Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 1, 2007 after 164 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922543 (1993). 4 ancestors in all.
276 later devices descend from it; 3 cite it directly.
1 of 281 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022070: Xantus Anterior Lateral Supplemental Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K020665: HI-OX, Sensor Medics Corp. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own
- 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

## Indications for use
The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation of the vascular structures or laterally above the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomeningocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

Source page: https://510kreport.com/device/K071416
Methodology: https://510kreport.com/methodology