Cleared Special

Volition Plating System (K210658) - FDA 510(k) Clearance

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

K210658 · Ortho Solutions UK , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
40d
Days
Class 2
Risk

K210658 is an FDA 510(k) clearance for the Volition 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 Ortho Solutions UK , Ltd. (Maldon, GB). The FDA issued a Cleared decision on April 13, 2021 after a review of 40 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 Ortho Solutions UK , Ltd. devices

Submission Details

510(k) Number K210658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2021
Decision Date April 13, 2021
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
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 698
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K210658.
DRPx Locking Distal Radius Plate System
K202971 · Orthopaedic Implant Company · May 2021
JACE Medical Thoracic Plating System
K210290 · Jace Medical, LLC · Apr 2021
SOLE Medial Column Fusion Plate
K210157 · Orthofix Srl · Apr 2021
DePuy Synthes Variable Angle Locking Patella Plating System
K210408 · Synthes USA Products, LLC · Apr 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
K210205 · Synthes USA Products, LLC · Mar 2021
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
K210534 · Gramercy Extremity Orthopedics, LLC · Mar 2021