# K240592: Wolff's Law Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Simplicity, LLC
- Decided: May 24, 2024 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: 6 generations back to K922087 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083020: Stryker Spine Reflex Translational Anterior Cervical Plating System, Stryker Corp. (2009) Summary page 4.
- K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System, Zimmer Spine, Inc. (2015) Summary page 4.
- K051665: Synthes Vectra-T System, Synthes Spine (2005) Summary page 4.

## Indications for use
The Wolff’s Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: • Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; • Spondylolisthesis; • Spinal Stenosis; • Trauma (including fractures); • Tumor; • Deformity (i.e., scoliosis, kyphosis, and/or lordosis); • Pseudoarthrosis; and • Failed previous fusions

Source page: https://510kreport.com/device/K240592
Methodology: https://510kreport.com/methodology