Cleared Traditional

K180777 - K2M Expandable Interbody System

K180777 is the FDA 510(k) clearance for K2M Expandable Interbody System by K2m, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K180777 · K2m, Inc. · Orthopedic device
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Aug 2018
Decision
130d
Days
Class 2
Risk

K180777 is an FDA 510(k) clearance for the K2M Expandable Interbody System. 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 K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on August 3, 2018 after a review of 130 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 K2m, Inc. devices

Submission Details

510(k) Number K180777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2018
Decision Date August 03, 2018
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 Consultant

K2m
Nancy Giezen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K180777.
Aries® Lumbar Interbodies
K181347 · Osseus Fusion Systems, LLC · Aug 2018
Duo™ Lumbar Interbody Fusion Device
K181792 · Spineology, Inc. · Aug 2018
TirboLOX-L Lumbar IBFD
K180990 · Captiva Spine, Inc. · Aug 2018
Ti 3Z Interbody System
K180076 · Zavation Medical Products, LLC · Jul 2018
Corelink Foundation 3D Anterior Lumbar System
K180556 · Corelink, LLC · Jul 2018
Lumbar Interbody Fusion System (OLLIF)
K173947 · Advanced Research Medical, LLC · Jul 2018