Cleared Traditional

K171686 - Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System

K171686 is an FDA 510(k) clearance for Choice Spine Hawkeye Vertebral Body Rep..., manufactured by Choicespine. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K171686 · Choicespine · Orthopedic device
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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.

View all Choicespine devices

FDA 510(k) Submission Details - K171686

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

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 237
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K171686.
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · Medtronic Sofamor Danek · Dec 2017
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
Omnia Medical VBR
K172323 · Omnia Medical, LLC · Oct 2017
CAPRI Corpectomy Cage System
K171704 · K2m · Aug 2017
VerteFIT Corpectomy Cage System
K162133 · Ldr Spine USA, Inc. · May 2017
CAPRI Corpectomy Cage System
K170055 · K2m · Apr 2017