# K123167: Depuy Pulse Anterior Cervical in-Line Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Dec 28, 2012 after 80 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: 5 generations back to K953730 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914362: Top Cervical Spine Plates & Titanium Bone Screws, Acorn Group, Inc. (1992) Summary page 1.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 1.
- K112724: Depuy Pulse Anterior Cerical Plate System, Medos International SARL (2011) Summary page 1.

## Indications for use
The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to TI. Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traimatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Source page: https://510kreport.com/device/K123167
Methodology: https://510kreport.com/methodology