# K050892: Hallmarktm Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: May 11, 2005 after 33 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922087 (1992). 15 ancestors in all.
52 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030595: Blackstone Fusion Anterior Cervical Plating System, Blackstone Medical, Inc. (2003) Summary page 1.
- K012184: Blackstone Iii Anterior Cervical Plating System, Blackstone Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates (2010), 51 descendants of its own
- K142060: Transom Anterior Cervical Plate (2014), 19 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K173521: SeaSpine Cabo ACP (Anterior Cervical Plate) System (2018), 15 descendants of its own

## Recalls of this device
- Mar 15, 2010 · Not classified · Z-1653-2010: The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
- May 8, 2006 · Not classified · Z-0478-2008: Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification

## Indications for use
The HallmarkTM Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Fracture; d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis) f) Tumor; g) Pseudoarthrosis; h) Revision of previous surgery

Source page: https://510kreport.com/device/K050892
Methodology: https://510kreport.com/methodology