Cleared Traditional

K173091 - Boundary Anterior Lumbar Buttress Plate

K173091 is an FDA 510(k) clearance for Boundary Anterior Lumbar Buttress Plate, manufactured by Nvision Biomedical Technologies, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K173091 · Nvision Biomedical Technologies, LLC · Orthopedic device
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Dec 2017
Decision
68d
Days
Class 2
Risk

K173091 is an FDA 510(k) clearance for the Boundary Anterior Lumbar Buttress Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, LLC (San Antonio, US). The FDA issued a Cleared decision on December 6, 2017 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nvision Biomedical Technologies, LLC devices

FDA 510(k) Submission Details - K173091

510(k) Number K173091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 06, 2017
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Acknowledge Regulatory Strategies, LLC
Allison C. Komiyama, Ph.D., R.A.C.

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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K173091.
SeaSpine Cabo ACP (Anterior Cervical Plate) System
K173521 · SeaSpine Orthopedics Corporation · Jan 2018
EZ Plate
K173306 · Zavation Medical Products, LLC · Jan 2018
Anterior Cervical Plate System
K173375 · Evolution Spine, LLC · Dec 2017
Fortis and Hana Anterior Cervical Plate System
K173099 · Huvexel Co. , Ltd. · Nov 2017
Liberty Anterior Cervical Plate
K172585 · Valorus Spine · Oct 2017
Shanghai Sanyou CARMEN Cervical Fusion System
K163366 · Shanghai Sanyou Medical Co, Ltd. · Oct 2017