Cleared Traditional

K152460 - Rectangular Corpectomy Cage

K152460 is an FDA 510(k) clearance for Rectangular Corpectomy Cage, manufactured by Amendia, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K152460 · Amendia, Inc. · Orthopedic device
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Dec 2015
Decision
116d
Days
Class 2
Risk

K152460 is an FDA 510(k) clearance for the Rectangular Corpectomy Cage. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on December 22, 2015 after a review of 116 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 Amendia, Inc. devices

FDA 510(k) Submission Details - K152460

510(k) Number K152460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2015
Decision Date December 22, 2015
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 K152460.
VerteFIT Corpectomy Cage System
K162133 · Ldr Spine USA, Inc. · May 2017
CAPRI Corpectomy Cage System
K170055 · K2m · Apr 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
SpineFab Vertebral Body Replacement (VBR) System
K142005 · Oxford Performance Materials · Jul 2015