# K251965: Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Aug 28, 2025 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: 32 generations back to K841189 (1984). 1,116 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213443: Insignia™ Anterior Cervical Plate System, Alphatec Spine, Inc. (2021) Summary page 5.
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System, Alphatec Spine, Inc. (2024) Summary page 5.
- K212446: NuVasive Anterior Cervical Plate Systems, Nu Vasive, Incorporated (2021) Summary page 5.

## Indications for use
The Proximity™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis. The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K251965
Methodology: https://510kreport.com/methodology