Cleared Special

K221465 - Baby Gorilla/Gorilla Plating System

K221465 is an FDA 510(k) clearance for Baby Gorilla/Gorilla Plating System, manufactured by Paragon 28, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 29-day FDA review.

K221465 · Paragon 28, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
29d
Days
Class 2
Risk

K221465 is an FDA 510(k) clearance for the Baby Gorilla/Gorilla 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 Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on June 17, 2022 after a review of 29 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.

FDA 510(k) Submission Details - K221465

510(k) Number K221465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2022
Decision Date June 17, 2022
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K221465.
Stryker VariAx 2 MIS Calcaneus
K221346 · Stryker GmbH · Jul 2022
Footmotion Plating System
K221395 · Newclip Technics · Jul 2022
Arthrex Mini Fragment System
K220937 · Arthrex, Inc. · Jun 2022
Omni Foot and Ankle Plating System
K221362 · Exremity Medical, LLC · Jun 2022
CoLink PCR Plating System
K213698 · In2bones USA, LLC · May 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979 · Nextremity Solutions, Inc. · May 2022
K221465 · Baby Gorilla/Gorilla Plating System
Download PDF FDA Summary Paragon 28, Inc.