Cleared Special

K222194 - Baby Gorilla/Gorilla Plating System

K222194 is the FDA 510(k) clearance for Baby Gorilla/Gorilla Plating System by Paragon 28, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 28-day FDA review.

K222194 · Paragon 28, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
28d
Days
Class 2
Risk

K222194 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 August 19, 2022 after a review of 28 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K222194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2022
Decision Date August 19, 2022
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K222194.
Bonebridge Osteosynthesis Plating System
K213864 · Bonebridge AG · Sep 2022
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935 · I.T.S. GmbH · Aug 2022
ARIX Small Fragment System
K221920 · Jeil Medical Corporation · Aug 2022
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