# K022965: Blackstone Classic Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Mar 28, 2003 after 203 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.
10 later devices descend from it; 2 cite it directly.
0 of 25 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) Summary page 1.
- K974885: Blackstone Medical Inc. Anterior Cervical Plate System, Blackstone Medical, Inc. (1998) Summary page 1.

## Most influential descendants
- K161524: Tangis Anterior Cervical Plate (2016), 8 descendants of its own
- K210424: Quantum Anterior Cervical Plate (2021), 4 descendants of its own
- K252611: aprevo® cervical plating system (2025), 3 descendants of its own
- K260570: corra™ cervical plating system (2026), 1 descendant of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own

## Indications for use
BlackstoneTM111" Anterior Cervical Plating 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) pseudarthrosis; h) revision of previous surgery

Source page: https://510kreport.com/device/K022965
Methodology: https://510kreport.com/methodology