Cleared Traditional

K151322 - Amendia Interbody Fusion Devices

K151322 is the FDA 510(k) clearance for Amendia Interbody Fusion Devices by Amendia, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K151322 · Amendia, Inc. · Orthopedic device
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Sep 2015
Decision
115d
Days
Class 2
Risk

K151322 is an FDA 510(k) clearance for the Amendia Interbody Fusion Devices. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on September 10, 2015 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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

Submission Details

510(k) Number K151322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date September 10, 2015
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 597
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151322.
Tritanium PL Cage
K152304 · Stryker · Nov 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
CONCORDE Bullet Spinal System
K151352 · Medos International SARL · Oct 2015
NuVasive CoRoent Lumbar System
K151472 · Nu Vasive, Incorporated · Sep 2015
Cascadia Interbody System
K150481 · K2m, Inc. · Aug 2015
LnK Lumbar Interbody Fusion Cage System
K151140 · L & K Biomed Co., Ltd. · Aug 2015