# K030595: Blackstone Fusion Anterior Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Apr 24, 2003 after 58 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: 4 generations back to K922087 (1992). 14 ancestors in all.
66 later devices descend from it; 5 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012184: Blackstone Iii Anterior Cervical Plating System, Blackstone Medical, Inc. (2002)
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000) Summary page 1.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K050892: Hallmarktm Anterior Cervical Plate System (2005), 52 descendants of its own
- 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

## Indications for use
The BlackstoneTMFusion Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from the C2 to C7. The specific 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/K030595
Methodology: https://510kreport.com/methodology