# K974525: Synthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Mar 2, 1998 after 90 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 K922855 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925351: Synthes (U.S.a.) Anterior Spinal Plate, Synthes (Usa) (1993) Summary page 1.
- K922855: Synthes Universal Spine Rod and Screw Fixation Sys, Synthes (Usa) (1993) Summary page 1.

## Indications for use
The Synthes Spine Anterior Thoracolumbar Rod Clamp (ATRC) System consists of a rod, a choice of three clamps, one bone screw and one set screw. It is intended for use in stabilizing bone graft following anterior decompression of burst fractures. vertebrectomy and vertebral body replacement in tumor patients. anterior fusion following failed posterior lumbar surgery. anterior fusion following severe disc degeneration. Degenerative Disc Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies correction of anterolateral lordotic deformities for the spine, lumbar scoliosis and pseudoarthrosis of the thoracolumbar spine. This system is intended for anterolateral intervertebral body screw fixation/attachment to the T8 - L5 spine.

Source page: https://510kreport.com/device/K974525
Methodology: https://510kreport.com/methodology