Cleared Traditional

K171797 - TRYPTIK2 C-Plate Anterior Cervical Plate System

K171797 is an FDA 510(k) clearance for TRYPTIK2 C-Plate Anterior Cervical Plat..., manufactured by Spineart. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K171797 · Spineart · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
255d
Days
Class 2
Risk

K171797 is an FDA 510(k) clearance for the TRYPTIK2 C-Plate Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on February 26, 2018 after a review of 255 days - an extended review 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: 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 Spineart devices

FDA 510(k) Submission Details - K171797

510(k) Number K171797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2017
Decision Date February 26, 2018
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
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 Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 595
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K171797.
Axis Anterior Cervical Plate System
K173867 · Axis Orthopaedics · Apr 2018
Genesys Spine Binary Lumbar Plate System
K173885 · Genesys Spine · Apr 2018
Zavation Buttress Plate System
K180537 · Zavation Medical Products, LLC · Mar 2018
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