Cleared Traditional

K233994 - VOLT™ Proximal Humerus 3.5 Plating System

K233994 is an FDA 510(k) clearance for VOLT Proximal Humerus 3.5 Plating System, manufactured by Synthes GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K233994 · Synthes GmbH · Orthopedic device
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Jul 2024
Decision
221d
Days
Class 2
Risk

K233994 is an FDA 510(k) clearance for the VOLT™ Proximal Humerus 3.5 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 Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on July 26, 2024 after a review of 221 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes GmbH devices

FDA 510(k) Submission Details - K233994

510(k) Number K233994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2023
Decision Date July 26, 2024
Days to Decision 221 days
Submission Type Traditional
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
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1224
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K233994.
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387 · In2bones USA · Aug 2024
Freefix Forearm Plating System
K242055 · Skeletal Dynamics, Inc. · Aug 2024
Activmotion S
K241539 · Newclip Technics · Jul 2024
Gaudi Proximal Humerus Plate
K241296 · Netbiologics, LLC · Jul 2024
KLS Martin Orthopedic Implants - MR Conditional
K241018 · KLS-Martin L.P. · Jul 2024
Versalock Rib and Sternum Plates System
K232829 · GM Dos Reis Industria e Comercio Ltda. · Jun 2024