Cleared Traditional

K113733 - SMALL AND LARGE FRAGMENTS OSTEOSYNTHESI...

K113733 is an FDA 510(k) clearance for SMALL AND LARGE FRAGMENTS OSTEOSYNTHESI..., manufactured by Neoortho Produtos Ortopedicos S/A. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K113733 · Neoortho Produtos Ortopedicos S/A · Orthopedic device
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Mar 2012
Decision
95d
Days
Class 2
Risk

K113733 is an FDA 510(k) clearance for the SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Neoortho Produtos Ortopedicos S/A (San Diego, US). The FDA issued a Cleared decision on March 23, 2012 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neoortho Produtos Ortopedicos S/A devices

FDA 510(k) Submission Details - K113733

510(k) Number K113733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date March 23, 2012
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 1037
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113733.
MINI MAXLOCK EXTREME PLATING SYSTEM
K120157 · Orthohelix Surgical Designs, Inc. · Apr 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
K120667 · Smith & Nephew, Inc. · Apr 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802 · Wrightmedicaltechnologyinc · Apr 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070 · Synthes (Usa) · Mar 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663 · DePuy Orthopaedics, Inc. · Mar 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · Synthes USA Products, LLC · Feb 2012