Cleared Special

K100070 - UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

K100070 is an FDA 510(k) clearance for UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 24-day FDA review.

K100070 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
24d
Days
Class 2
Risk

K100070 is an FDA 510(k) clearance for the UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on February 4, 2010 after a review of 24 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 - K100070

510(k) Number K100070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2010
Decision Date February 04, 2010
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 664
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K100070.
NUVASIVE HELIX REVOLUTION ACP SYSTEM
K093804 · Nuvasive, Inc. · Feb 2010
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
K100061 · K2m, Inc. · Feb 2010
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
K092531 · Spine360 · Feb 2010
ACP4 SPINAL IMPLANT SYSTEM
K092360 · X-Spine Systems, Inc. · Jan 2010
AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
K092124 · Trans1 Incorporated · Jan 2010
BLADE ANTERIOR CERVICAL PLATE SYSTEM
K091936 · Nexxt Medical, Inc. · Jan 2010
K100070 · UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
Download PDF FDA Summary Depuy Spine, Inc.