# K142060: Transom Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Nov 18, 2014 after 112 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: 7 generations back to K922087 (1992). 28 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131374: Tempus (TM) Cervical Plate System, Neurostructures, LLC (2013) Summary page 4.
- K120515: Tempus Cervical Plate System, Neurostructures, LLC (2012) Summary page 4.
- K974885: Blackstone Medical Inc. Anterior Cervical Plate System, Blackstone Medical, Inc. (1998) Summary page 5.
- K012184: Blackstone Iii Anterior Cervical Plating System, Blackstone Medical, Inc. (2002) Summary page 5.
- K030595: Blackstone Fusion Anterior Cervical Plating System, Blackstone Medical, Inc. (2003) Summary page 5.
- K050892: Hallmarktm Anterior Cervical Plate System, Blackstone Medical, Inc. (2005) Summary page 5.
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates, Blackstone Medical, Inc. (2010) Summary page 5.

## Most influential descendants
- K173521: SeaSpine Cabo ACP (Anterior Cervical Plate) System (2018), 15 descendants of its own
- K202064: Admiral ACP System (2020), 14 descendants of its own
- K211903: Shoreline Threaded TruProfile® Plate (2021), 7 descendants of its own
- K212139: Admiral ACP System (2021), 6 descendants of its own
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 descendants of its own

## Indications for use
The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: 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.

Source page: https://510kreport.com/device/K142060
Methodology: https://510kreport.com/methodology