Cleared Traditional

K181190 - Pinehurst Anterior Cervical Plate System

K181190 is an FDA 510(k) clearance for Pinehurst Anterior Cervical Plate System, manufactured by Signature Orthopaedics Pty, Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K181190 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
258d
Days
Class 2
Risk

K181190 is an FDA 510(k) clearance for the Pinehurst Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on January 17, 2019 after a review of 258 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 Signature Orthopaedics Pty, Ltd. devices

FDA 510(k) Submission Details - K181190

510(k) Number K181190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2018
Decision Date January 17, 2019
Days to Decision 258 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
136d slower than avg
Panel avg: 122d · This submission: 258d
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 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K181190.
Athena II Cervical Plate System
K183409 · Medyssey USA, Inc. · Feb 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System
K182885 · Medtronic Sofamor Danek USA, Inc. · Feb 2019
SECULOK™ ACP System
K190053 · U&I Corporation · Feb 2019
CervAlign™ Anterior Cervical Plate System
K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2019
4CIS® Pinehurst Anterior Cervical Plate system
K182489 · Solco Biomedical Co., Ltd. · Jan 2019
Raven Lumbar Plate System
K183214 · Choicespine, LP · Jan 2019