# K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Feb 12, 1999 after 39 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922087 (1992). 4 ancestors in all.
313 later devices descend from it; 5 cite it directly.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973854: Orion Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1998) Summary page 1.
- K922087: Anterior Cervical Plate System, Sofamor Danek Mfg., Inc. (1992) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.

## Most influential descendants
- K000486: Abc Cervical Plating System (2000), 289 descendants of its own
- K050813: Abc 2 Screw (2005), 145 descendants of its own
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K122910: Archon Anterior Cervical Plate Syste, (2012), 101 descendants of its own

## Recalls of this device
- Nov 14, 2005 · Not classified · Z-0292-06: Modification to labeling for surgical implant.

## Indications for use
The Spinal Concepts, Inc. (SCI) 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: 1. Degenerative disc disease (DDD) — 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/K990005
Methodology: https://510kreport.com/methodology