# K112724: Depuy Pulse Anterior Cerical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Nov 21, 2011 after 63 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 K953730 (1995). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 1.
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 1.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K171439: EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System (2017), 0 descendants of its own
- K123167: Depuy Pulse Anterior Cervical in-Line Plate System (2012), 0 descendants of its own

## Indications for use
The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

Source page: https://510kreport.com/device/K112724
Methodology: https://510kreport.com/methodology