Cleared Traditional

K091926 - CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

K091926 is an FDA 510(k) clearance for CHOICE SPINE ANTERIOR CERVICAL PLATE (A..., manufactured by Choicespine, LP. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K091926 · Choicespine, LP · Orthopedic device
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Dec 2009
Decision
175d
Days
Class 2
Risk

K091926 is an FDA 510(k) clearance for the CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Choicespine, LP (Chesterland, US). The FDA issued a Cleared decision on December 22, 2009 after a review of 175 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 Choicespine, LP devices

FDA 510(k) Submission Details - K091926

510(k) Number K091926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date December 22, 2009
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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 550
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K091926.
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K100070 · Depuy Spine, Inc. · Feb 2010
ACP4 SPINAL IMPLANT SYSTEM
K092360 · X-Spine Systems, Inc. · Jan 2010
LIFE SPINE LUMBAR PLATE SYSTEM
K093200 · Life Spine · Jan 2010
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
K092659 · Spinal USA · Nov 2009
XTEND ANTERIOR CERVICAL PLATE SYSTEM
K092146 · Globus Medical, Inc. · Nov 2009
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · Globus Medical, Inc. · Aug 2009