# K984342: Anterior Cervical Plating System

- Pathway: 510(k) (Special)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 30, 1998 after 26 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K843523: Empty Solution Transfer Container 1000, Polymer Technology Corp. (1984). Our OCR of the scanned summary read K843523, FDA’s number for Empty Solution Transfer Container 1000 (Polymer Technology Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ALINE™ Anterior Cervical Plating System”. Kept off the family tree. Summary page 1.

## Indications for use
The ALINE™ Anterior Cervical Plating System is designed to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and tumors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation enly.

Source page: https://510kreport.com/device/K984342
Methodology: https://510kreport.com/methodology