Cleared Traditional

K140216 - ORTHOPEDIC FIXATION SYSTEMS

K140216 is an FDA 510(k) clearance for ORTHOPEDIC FIXATION SYSTEMS, manufactured by Impact Medical, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K140216 · Impact Medical, LLC · Orthopedic device
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May 2014
Decision
93d
Days
Class 2
Risk

K140216 is an FDA 510(k) clearance for the ORTHOPEDIC FIXATION SYSTEMS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Impact Medical, LLC (Portland, US). The FDA issued a Cleared decision on May 1, 2014 after a review of 93 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 Impact Medical, LLC devices

FDA 510(k) Submission Details - K140216

510(k) Number K140216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2014
Decision Date May 01, 2014
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140216.
AAP LOQTEC(R) OLECRANON PLATE
K140607 · Aap Implantate AG · May 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · Smith & Nephew, Inc. · May 2014
MATRIXRIB FIXATION SYSTEM
K133616 · Synthes USA Products, LLC · May 2014
PINIT SMALL BONE FUSION SYSTEM
K140617 · Arthrosurface, Inc. · Apr 2014
VARIAX 2 SYSTEM
K140769 · Stryker Trauma AG · Apr 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069 · Merete Medical GmbH · Apr 2014