Cleared Special

K051908 - CHARLOTTE COMPRESSION PLATE

K051908 is an FDA 510(k) clearance for CHARLOTTE COMPRESSION PLATE, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 27-day FDA review.

K051908 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2005
Decision
27d
Days
Class 2
Risk

K051908 is an FDA 510(k) clearance for the CHARLOTTE COMPRESSION PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 10, 2005 after a review of 27 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.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K051908

510(k) Number K051908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2005
Decision Date August 10, 2005
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1263
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K051908.
SBI WRISTFIT
K051747 · Small Bone Innovations, LLC · Sep 2005
MIOT PLATING SYSTEM
K051945 · Orthofix Srl · Sep 2005
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
K051567 · Medartis, Inc. · Aug 2005
PILONPLATE WITH ANGULAR STABILITY
K052011 · I.T.S. Implantat-Technologie-Systeme GmbH · Aug 2005
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
K050655 · Kapp Surgical Instrument, Inc. · Aug 2005
MONDEAL CONTOUR HO SYSTEM
K050657 · Kapp Surgical Instrument, Inc. · Aug 2005