Cleared Traditional

K112595 - COFLEX-F

K112595 is an FDA 510(k) clearance for COFLEX-F, manufactured by Paradigm Spine, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K112595 · Paradigm Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
159d
Days
Class 2
Risk

K112595 is an FDA 510(k) clearance for the COFLEX-F. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Paradigm Spine, LLC (New York, US). The FDA issued a Cleared decision on February 13, 2012 after a review of 159 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Paradigm Spine, LLC devices

FDA 510(k) Submission Details - K112595

510(k) Number K112595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date February 13, 2012
Days to Decision 159 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
37d slower than avg
Panel avg: 122d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 337
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K112595.
VERTEX RCCONSTRUCTION SYSTEM
K121191 · Medtronic Sofamor Danek, Inc. · Jun 2012
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
K112757 · Pioneer Surgical Technology, Inc. · Mar 2012
NEON SYSTEM
K113346 · Ulrich GmbH & Co. KG · Feb 2012
OASYS SPINAL SYSTEM
K111719 · Stryker Spine · Jan 2012
CASPIAN
K113654 · K2m, Inc. · Jan 2012
AXLE PEEK INTERSPINOUS FUSION SYSTEM
K112592 · X-Spine Systems, Inc. · Dec 2011