Cleared Special

K091609 - NEWDEAL COMPRESSION PLATE

K091609 is an FDA 510(k) clearance for NEWDEAL COMPRESSION PLATE, manufactured by Newdeal Sas. 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.

K091609 · Newdeal Sas · Orthopedic device
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Jun 2009
Decision
27d
Days
Class 2
Risk

K091609 is an FDA 510(k) clearance for the NEWDEAL 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 Newdeal Sas (Planisboro, US). The FDA issued a Cleared decision on June 30, 2009 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 Newdeal Sas devices

FDA 510(k) Submission Details - K091609

510(k) Number K091609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date June 30, 2009
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 1054
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K091609.
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522 · Osteomed LP · Jul 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582 · Tornier, Inc. · Jul 2009
APTUS 2.0/2.3 FOUR CORNER FUSION PLATE
K090983 · Medartis AG · Jul 2009
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
K090877 · DePuy Orthopaedics, Inc. · Jun 2009
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243 · Wrightmedicaltechnologyinc · Jun 2009
CLAVICLE PLATING SYSTEM
K090289 · Orthohelix Surgical Designs, Inc. · Jun 2009