# K013665: Pyramid Anterior Plate Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jan 29, 2002 after 84 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: 1 generation back to K922543 (1993). 3 ancestors in all.
248 later devices descend from it; 12 cite it directly.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 1.
- K010632: Butterfly Plate Function System, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 1.
- K994122: Bone Graft Washer, Model 9090114 - 9090118, Danek Medical, Inc. (2000) Summary page 2.

## Most influential descendants
- K052546: Aegis Anterior Lumbar Plate System (2006), 211 descendants of its own
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System (2005), 211 descendants of its own
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System (2006), 165 descendants of its own
- K070922: Modification to Spinal Usa VBR System (2007), 161 descendants of its own
- K091044: Spinal Usa Anterior Lumbar Plate System (2009), 159 descendants of its own

## Indications for use
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below 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 myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Source page: https://510kreport.com/device/K013665
Methodology: https://510kreport.com/methodology