# K013979: SC-Acufix Thinline Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Spinal Concepts, Inc.
- Decided: Feb 13, 2002 after 72 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922087 (1992). 5 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System, Spinal Concepts, Inc. (1999) Summary page 1.

## Most influential descendants
- K024326: Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System (2003), 19 descendants of its own
- K052072: The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates (2005), 17 descendants of its own
- 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 (2015), 16 descendants of its own
- K192481: AccelFix Lumbar Plate System (2020), 13 descendants of its own
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own

## Recalls of this device
- Nov 14, 2005 · Not classified · Z-0292-06: Modification to labeling for surgical implant.
- Jul 1, 2002 · Not classified · Z-0880-05: Complaints were recieved where swivels came out of plate and where the screw went through the plate.

## Indications for use
The SC-AcuFix Thinline 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 (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

Source page: https://510kreport.com/device/K013979
Methodology: https://510kreport.com/methodology