Cleared Traditional

K143350 - Nile Alternative Fixation

K143350 is an FDA 510(k) clearance for Nile Alternative Fixation, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K143350 · K2m, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
93d
Days
Class 2
Risk

K143350 is an FDA 510(k) clearance for the Nile Alternative Fixation. 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 February 25, 2015 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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

FDA 510(k) Submission Details - K143350

510(k) Number K143350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2014
Decision Date February 25, 2015
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWI Device Classification - Class 2, Special Controls

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 Peers - OWI Bone Fixation Cerclage, Sublaminar

All 36
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K143350.
NILE Alternative Fixation Spinal System
K160208 · K2m, Inc. · Mar 2016
JAZZ System
K151740 · Implanet, S.A. · Aug 2015
JAZZ System
K143759 · Implanet, S.A. · May 2015
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
K142053 · Zimmer Spine, Inc. · Oct 2014
SILC FIXATION SYSTEM
K133482 · Globus Medical, Inc. · May 2014
JAZZ SYSTEM
K133617 · Implanet, S.A. · Feb 2014