Cleared Special

K051971 - OPTIMA SPINAL SYSTEM

K051971 is an FDA 510(k) clearance for OPTIMA SPINAL SYSTEM, manufactured by U&I Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 14-day FDA review.

K051971 · U&I Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
14d
Days
Class 2
Risk

K051971 is an FDA 510(k) clearance for the OPTIMA SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by U&I Corp. (Uijungbu, Gyeonggi-Do, KR). The FDA issued a Cleared decision on August 4, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051971

510(k) Number K051971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2005
Decision Date August 04, 2005
Days to Decision 14 days
Submission Type Special
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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 657
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K051971.
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
SYNTHES VECTRA-T SYSTEM
K051665 · Synthes Spine · Sep 2005
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
K052072 · Abbott Spine, Inc. · Aug 2005
T-PLATE ANTERIOR FIXATION SYSTEM
K051764 · Esm Technologies · Jul 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · Blackstone Medical, Inc. · Jun 2005
TRANS1 AXIALIF SYSTEM
K050965 · Trans1 Incorporated · Jun 2005