Cleared Special

K160208 - NILE Alternative Fixation Spinal System

K160208 is the FDA 510(k) clearance for NILE Alternative Fixation Spinal System by K2m, Inc.. It is a Class 2 Orthopedic device (product code OWI) cleared through the Special 510(k) pathway after a 50-day FDA review.

K160208 · K2m, Inc. · Orthopedic device
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Mar 2016
Decision
50d
Days
Class 2
Risk

K160208 is an FDA 510(k) clearance for the NILE Alternative Fixation Spinal System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on March 18, 2016 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all K2m, Inc. devices

Submission Details

510(k) Number K160208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2016
Decision Date March 18, 2016
Days to Decision 50 days
Submission Type Special
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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OWI Bone Fixation Cerclage, Sublaminar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
Definition Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.
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 - OWI Bone Fixation Cerclage, Sublaminar

All 25
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K160208.
NILE Proximal Fixation Spinal System
K161332 · K2m, Inc. · Apr 2017
Response BandLoc Spinal Fixation
K161267 · OrthoPediatrics Corp. · Aug 2016
NuVasive® VersaTie System
K161265 · Nu Vasive, Incorporated · Jul 2016
Nile Alternative Fixation
K143350 · K2m, Inc. · Feb 2015
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
K142053 · Zimmer Spine, Inc. · Oct 2014
SILC FIXATION SYSTEM
K133482 · Globus Medical, Inc. · May 2014