Cleared Traditional

K171686 - Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171686 · Choicespine · Orthopedic device
Sep 2017
Decision
100d
Days
Class 2
Risk

K171686 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 September 15, 2017 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K171686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2017
Decision Date September 15, 2017
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 116d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.