# K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: May 4, 2010 after 61 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: 6 generations back to K922087 (1992). 22 ancestors in all.
51 later devices descend from it; 7 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050892: Hallmarktm Anterior Cervical Plate System, Blackstone Medical, Inc. (2005) Summary page 1.
- K073479: Kinetic-SL Anterior Cervical Plate System, Life Spine (2008) Summary page 1.

## Most influential descendants
- 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
- K202064: Admiral ACP System (2020), 14 descendants of its own

## Indications for use
The Hallmark 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/K100614
Methodology: https://510kreport.com/methodology