Cleared Special

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (K183588) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K183588 · Choicespine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
63d
Days
Class 2
Risk

K183588 is an FDA 510(k) clearance for the Choice Spine Hawkeye Vertebral Body Replacement (VBR) System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Choicespine (Knoxville, US). The FDA issued a Cleared decision on February 22, 2019 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Choicespine devices

Submission Details

510(k) Number K183588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date February 22, 2019
Days to Decision 63 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQP Spinal Vertebral Body Replacement Device

All 276
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K183588.
VyBrate™ VBR System
K253158 · Vy Spine, LLC · Jan 2026
Vertiwedge® Intraosseous System
K241468 · Foundation Surgical Group, Inc. · Nov 2024
KONG®-TL VBR System and KONG® C VBR System
K232790 · Icotec AG · Apr 2024
DOMINION Expandable Corpectomy System
K233359 · Astura Medical · Mar 2024
VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023