Cleared Traditional

NEWDEAL TIBIAXYS SYSTEM (K073375) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073375 · Newdeal Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
80d
Days
Class 2
Risk

K073375 is an FDA 510(k) clearance for the NEWDEAL TIBIAXYS SYSTEM. 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 February 21, 2008 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Newdeal Sas devices

Submission Details

510(k) Number K073375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date February 21, 2008
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K073375.
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522 · Synthes (Usa) · May 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · Howmedica Osteonics Corp. · Mar 2008
CHARLOTTE CLAW 3.5
K080295 · Wrightmedicaltechnologyinc · Feb 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460 · Synthes (Usa) · Feb 2008
BIOFOAM BONE WEDGE
K073535 · Wrightmedicaltechnologyinc · Jan 2008
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186 · Synthes (Usa) · Dec 2007