# K980228: University Plate Anterior System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Apr 14, 1998 after 82 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 K904446 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904446: Casf (TM) (Contoured Anterior Spinal Fixaton Sys.), Acromed Corp. (1991) Summary page 2.
- K923703: Kaneda Anterior Spinal Multisegmental Fixation Dev, Acromed Corp. (1993) Summary page 2.
- K943819: Isola Anterior System, Acromed Corp. (1995) Summary page 2.

## Most influential descendants
- K192281: AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System (2019), 0 descendants of its own

## Indications for use
The University™ Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

Source page: https://510kreport.com/device/K980228
Methodology: https://510kreport.com/methodology