# 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

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 20, 2017 after 65 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072546: Swift Plus Anterior Cervical Plate System, Depuy Spine, Inc. (2007) Summary page 6.
- K070994: Eagle + Anterior Cervical Plate System, Depuy Spine, Inc. (2007) Summary page 6.
- K080191: Eagle Plus Micro Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 6.
- K112724: Depuy Pulse Anterior Cerical Plate System, Medos International SARL (2011) Summary page 6.
- K052552: Hybrid Anterior Cervical Plate System, Depuy Spine, Inc. (2005) Summary page 6.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 6.
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 6.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 6.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 6.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 6.

## Indications for use
The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 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. The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are 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 T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications. The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis. The 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/K171439
Methodology: https://510kreport.com/methodology