# K162194: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Dec 8, 2016 after 125 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: 6 generations back to K953730 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.
- K052763: Stella Cervical Plate, Scient'X (2005) Summary page 4.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 6.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 4.

## Indications for use
MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/plate fixation of the cervical spine until the bone fusion occurs. The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions: • degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), • spondylolisthesis, • trauma (i.e., fracture or dislocation), • spinal stenosis, • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), • tumor, • pseudoarthrosis, • and failed previous fusion This implant has to be used with an appropriate bone graft. Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.

Source page: https://510kreport.com/device/K162194
Methodology: https://510kreport.com/methodology