Cleared Traditional

K012045 - HIGHGATE CURVED ROD SYSTEM

K012045 is an FDA 510(k) clearance for HIGHGATE CURVED ROD SYSTEM, manufactured by Highgate Orthopaedics. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K012045 · Highgate Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
256d
Days
Class 2
Risk

K012045 is an FDA 510(k) clearance for the HIGHGATE CURVED ROD SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Highgate Orthopaedics (Chesterland, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 256 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 Highgate Orthopaedics devices

FDA 510(k) Submission Details - K012045

510(k) Number K012045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date March 12, 2002
Days to Decision 256 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 122d · This submission: 256d
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 553
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K012045.
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244 · Synthes Spine · Apr 2002
ENVISION ANTERIOR CERVICAL PLATE SYSTEM
K020649 · Ortho Development Corp. · Apr 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · Howmedica Osteonics Corp. · Mar 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979 · Spinal Concepts, Inc. · Feb 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · Endius, Inc. · Feb 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · Blackstone Medical, Inc. · Jan 2002