Cleared Special

K110354 - 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM

K110354 is an FDA 510(k) clearance for 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code JDP cleared through the Special 510(k) pathway after a 25-day FDA review.

K110354 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
25d
Days
Class 2
Risk

K110354 is an FDA 510(k) clearance for the 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM. Classified as Condylar Plate Fixation Implant (product code JDP), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 4, 2011 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K110354

510(k) Number K110354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2011
Decision Date March 04, 2011
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

JDP Device Classification - Class 2, Special Controls

Product Code JDP Condylar Plate Fixation Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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.

K110354 · 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
Download PDF FDA Summary Synthes (Usa)