Cleared Special

Omni Foot and Ankle Plating System (K221362) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221362 · Exremity Medical, LLC · Orthopedic device
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Jun 2022
Decision
30d
Days
Class 2
Risk

K221362 is an FDA 510(k) clearance for the Omni Foot and Ankle Plating 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 Exremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on June 10, 2022 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exremity Medical, LLC devices

Submission Details

510(k) Number K221362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2022
Decision Date June 10, 2022
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K221362.
Footmotion Plating System
K221395 · Newclip Technics · Jul 2022
Arthrex Mini Fragment System
K220937 · Arthrex, Inc. · Jun 2022
Baby Gorilla/Gorilla Plating System
K221465 · Paragon 28, Inc. · Jun 2022
CoLink PCR Plating System
K213698 · In2bones USA, LLC · May 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979 · Nextremity Solutions, Inc. · May 2022
Osteotomy Truss System (OTS)
K220463 · 4Web Medical, Inc. · May 2022