Cleared Traditional

K171704 - CAPRI Corpectomy Cage System

K171704 is the FDA 510(k) clearance for CAPRI Corpectomy Cage System by K2m. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K171704 · K2m · Orthopedic device
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Aug 2017
Decision
84d
Days
Class 2
Risk

K171704 is an FDA 510(k) clearance for the CAPRI Corpectomy Cage System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on August 31, 2017 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K171704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2017
Decision Date August 31, 2017
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
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.

Regulatory Peers - MQP Spinal Vertebral Body Replacement Device

All 153
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K171704.
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800 · Camber Spine Technologies · Feb 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · Medtronic Sofamor Danek · Dec 2017
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
NuVasive PEEK Corpectomy Railed System
K151538 · Nu Vasive, Incorporated · Sep 2015
NuVasive PEEK Corpectomy System
K151167 · Nu Vasive, Incorporated · Sep 2015