Cleared Traditional

K093914 - NEWDEAL COMPRESSION PLATES

K093914 is an FDA 510(k) clearance for NEWDEAL COMPRESSION PLATES, manufactured by Newdeal Sas. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 478-day FDA review.

K093914 · Newdeal Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
478d
Days
Class 2
Risk

K093914 is an FDA 510(k) clearance for the NEWDEAL COMPRESSION PLATES. 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 April 14, 2011 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Newdeal Sas devices

FDA 510(k) Submission Details - K093914

510(k) Number K093914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date April 14, 2011
Days to Decision 478 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
356d slower than avg
Panel avg: 122d · This submission: 478d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K093914.
MINI VARIABLE SYSTEM
K111041 · Orthohelix Surgical Designs, Inc. · Jun 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039 · Zimmer, Inc. · May 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · Synthes (Usa) · Apr 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476 · Stryker Corp. · Mar 2011
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
K110176 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2011
APTUS ULNA PLATES
K103332 · Medartis AG · Jan 2011