Cleared Traditional

K161332 - NILE Proximal Fixation Spinal System

K161332 is an FDA 510(k) clearance for NILE Proximal Fixation Spinal System, 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 328-day FDA review.

K161332 · K2m, Inc. · Orthopedic device
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Apr 2017
Decision
328d
Days
Class 2
Risk

K161332 is an FDA 510(k) clearance for the NILE Proximal 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 April 5, 2017 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K161332

510(k) Number K161332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date April 05, 2017
Days to Decision 328 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
206d slower than avg
Panel avg: 122d · This submission: 328d
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 K161332.
JAZZ Passer Band
K171881 · Implanet, S.A. · Aug 2017
JAZZ System, including JAZZ Band
K170730 · Implanet, S.A. · Jun 2017
TRANSLACE™ Spinal Tethering System
K163181 · Medtronic Sofamor Danek USA, Inc. · May 2017
LigaPASS
K160698 · Medicrea International SA · Sep 2016
Response BandLoc Spinal Fixation
K161267 · OrthoPediatrics Corp. · Aug 2016
NuVasive® VersaTie System
K161265 · Nu Vasive, Incorporated · Jul 2016