Cleared Special

K022255 - MODOFOCATION TO SYNTHES ANKLE ARTHRODES...

K022255 is the FDA 510(k) clearance for MODOFOCATION TO SYNTHES ANKLE ARTHRODES... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 13-day FDA review.

K022255 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
13d
Days
Class 2
Risk

K022255 is an FDA 510(k) clearance for the MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 25, 2002 after a review of 13 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 Synthes (Usa) devices

Submission Details

510(k) Number K022255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date July 25, 2002
Days to Decision 13 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
109d faster than avg
Panel avg: 122d · This submission: 13d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K022255.
SMALL TITANIUM WRIST FUSION PLATE
K023879 · Synthes (Usa) · Feb 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · Synthes (Usa) · Jan 2003
BIOMET CALCANEAL PLATE
K022515 · Biomet Orthopedics, Inc. · Sep 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · Synthes (Usa) · Jul 2002
WRIST FUSION PLATE
K021321 · Acu Med, Inc. · Jul 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · Synthes (Usa) · Jun 2002