# K182489: 4CIS® Pinehurst Anterior Cervical Plate system

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Jan 16, 2019 after 127 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: 8 generations back to K953730 (1995). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141632: Zevo (TM) Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 4.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 4.
- K072650: Ist Anterior Cervical Plate System, Innovative Spinal Technologies, Inc. (2007) Summary page 4.

## Most influential descendants
- K223321: Omnia Medical Coupler-C Anterior Cervical Plate (2023), 0 descendants of its own

## Indications for use
The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.

Source page: https://510kreport.com/device/K182489
Methodology: https://510kreport.com/methodology