Cleared Traditional

K161267 - Response BandLoc Spinal Fixation

K161267 is an FDA 510(k) clearance for Response BandLoc Spinal Fixation, manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K161267 · OrthoPediatrics Corp. · Orthopedic device
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Aug 2016
Decision
98d
Days
Class 2
Risk

K161267 is an FDA 510(k) clearance for the Response BandLoc Spinal Fixation. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on August 11, 2016 after a review of 98 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 OrthoPediatrics Corp. devices

FDA 510(k) Submission Details - K161267

510(k) Number K161267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2016
Decision Date August 11, 2016
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 K161267.
TRANSLACE™ Spinal Tethering System
K163181 · Medtronic Sofamor Danek USA, Inc. · May 2017
NILE Proximal Fixation Spinal System
K161332 · K2m, Inc. · Apr 2017
LigaPASS
K160698 · Medicrea International SA · Sep 2016
NuVasive® VersaTie System
K161265 · Nu Vasive, Incorporated · Jul 2016
JAZZ LOCK
K153348 · Implanet, S.A. · Mar 2016
NILE Alternative Fixation Spinal System
K160208 · K2m, Inc. · Mar 2016