# K181190: Pinehurst Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Jan 17, 2019 after 258 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 K922087 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143279: LnK Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K013979: SC-Acufix Thinline Anterior Cervical Plate System, Spinal Concepts, Inc. (2002) Summary page 4.
- K162638: CETRA Anterior Cervical Plate System, Orthofix, Inc. (2016) Summary page 4.
- K070775: Modification to: Providence Anterior Cervical Plate System, Globus Medical, Inc. (2007) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 4.
- K163625: NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System, Signature Orthopaedics Pty, Ltd. (2017) Summary page 4.

## Indications for use
The Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with: • Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); • Spondylolisthesis; • Trauma (I.e fracture or dislocations); • Tumors; • Deformity (defined as kyphosis, lordosis, or scoliosis); • Pseudoarthrosis; • Failed previous fusion; • Spinal stenosis

Source page: https://510kreport.com/device/K181190
Methodology: https://510kreport.com/methodology