Cleared Traditional

K173885 - Genesys Spine Binary Lumbar Plate System

K173885 is the FDA 510(k) clearance for Genesys Spine Binary Lumbar Plate System by Genesys Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K173885 · Genesys Spine · Orthopedic device
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Apr 2018
Decision
103d
Days
Class 2
Risk

K173885 is an FDA 510(k) clearance for the Genesys Spine Binary Lumbar Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on April 3, 2018 after a review of 103 days - within the typical 510(k) review window.

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: 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 Genesys Spine devices

Submission Details

510(k) Number K173885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date April 03, 2018
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K173885.
Cure™ Lumbar Plate System
K180090 · Meditech Spine, LLC · Apr 2018
Mediant Anterior Cervical Plating System
K173935 · Intelligent Implant Systems, LLC · Apr 2018
Axis Anterior Cervical Plate System
K173867 · Axis Orthopaedics · Apr 2018
Zavation Buttress Plate System
K180537 · Zavation Medical Products, LLC · Mar 2018
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · Spineart · Feb 2018
SeaSpine Cabo ACP (Anterior Cervical Plate) System
K173521 · SeaSpine Orthopedics Corporation · Jan 2018