# K101353: Golden Gate Anterior Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Feb 4, 2011 after 266 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: 4 generations back to K983583 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 2.
- K002824: Macs Modular Anterior Construct System, Aesculap, Inc. (2001) Summary page 2.
- K032059: Modification to Macs Modular Anterior Construct System, Aesculap, Inc. (2003) Summary page 2.
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 2.

## Indications for use
The golden gateTM anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate TM System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: * DDID (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), * Spondylolisthesis, * Spondylolysis, * Fracture (including dislocation or subluxation), * Spinal stenosis, * Deformity (i.e., scoliosis, kyphosis, lordosis), * Tumor, * Pseudarthrosis, Revision of previous surgery

Source page: https://510kreport.com/device/K101353
Methodology: https://510kreport.com/methodology