Cleared Traditional

K170055 - CAPRI Corpectomy Cage System

K170055 is an FDA 510(k) clearance for CAPRI Corpectomy Cage System, manufactured by K2m. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K170055 · K2m · Orthopedic device
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Apr 2017
Decision
97d
Days
Class 2
Risk

K170055 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 April 13, 2017 after a review of 97 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 K2m devices

FDA 510(k) Submission Details - K170055

510(k) Number K170055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2017
Decision Date April 13, 2017
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 K170055.
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
K171686 · Choicespine · Sep 2017
CAPRI Corpectomy Cage System
K171704 · K2m · Aug 2017
VerteFIT Corpectomy Cage System
K162133 · Ldr Spine USA, Inc. · May 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
Rectangular Corpectomy Cage
K152460 · Amendia, Inc. · Dec 2015
NuVasive PEEK Corpectomy Railed System
K151538 · Nu Vasive, Incorporated · Sep 2015