Cleared Traditional

K181190 - Pinehurst Anterior Cervical Plate System

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

K181190 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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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

Submission Details

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.

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 432
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