Cleared Special

K063820 - LISFRANC PLATE

K063820 is an FDA 510(k) clearance for LISFRANC PLATE, manufactured by New Deal, S.A.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 44-day FDA review.

K063820 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
44d
Days
Class 2
Risk

K063820 is an FDA 510(k) clearance for the LISFRANC 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 New Deal, S.A. (Planisboro, US). The FDA issued a Cleared decision on February 8, 2007 after a review of 44 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 New Deal, S.A. devices

FDA 510(k) Submission Details - K063820

510(k) Number K063820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date February 08, 2007
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 1284
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063820.
STRYKER FOOT PLATING SYSTEM
K063875 · Howmedica Osteonics Corp. · Mar 2007
PLC SUTURE ANCHOR
K063726 · Smith & Nephew Inc., Endoscopy Div. · Mar 2007
DALL-MILES SYSTEM
K070170 · Stryker Orthopaedics · Mar 2007
MODIFICATION TO TTC PLATES
K070160 · New Deal, S.A. · Feb 2007
MODIFICATION TO LAPIDUS PLATE
K070241 · New Deal, S.A. · Feb 2007
BASAL DORSAL PLATES
K063831 · Newdeal Sas · Feb 2007