Cleared Traditional

K162874 - Cannulated Screws Neoortho

K162874 is an FDA 510(k) clearance for Cannulated Screws Neoortho, manufactured by Neoortho Produtos Ortopedicos S/A. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K162874 · Neoortho Produtos Ortopedicos S/A · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
257d
Days
Class 2
Risk

K162874 is an FDA 510(k) clearance for the Cannulated Screws Neoortho. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Neoortho Produtos Ortopedicos S/A (Curitiba, BR). The FDA issued a Cleared decision on June 27, 2017 after a review of 257 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K162874

510(k) Number K162874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2016
Decision Date June 27, 2017
Days to Decision 257 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
135d slower than avg
Panel avg: 122d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 729
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K162874.
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · Extremity Medical, LLC · Jul 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571 · Tyber Medical, LLC · Jun 2017
2-Piece Hammertoe Correction System
K162685 · Life Spine, Inc. · Jun 2017
ALLY(TM) Bone Screws
K170698 · Providence Medical Technology, Inc. · May 2017