Cleared Traditional

K254054 - VOLT Ankle Trauma 2.7/3.5 Plating System

Also marketed or referenced as:
VOLT™ Calcaneus 2.7 Plating System

K254054 is the FDA 510(k) clearance for VOLT Ankle Trauma 2.7/3.5 Plating System by Synthes GmbH. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K254054 · Synthes GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
75d
Days
Class 2
Risk

K254054 is an FDA 510(k) clearance for the VOLT™ Ankle Trauma 2.7/3.5 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 March 2, 2026 after a review of 75 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes GmbH devices

Submission Details

510(k) Number K254054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2025
Decision Date March 02, 2026
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K254054.
Xpert Hand
K253906 · Newclip Technics · Mar 2026
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K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK™ Fixation System
K252166 · Globus Medical, Inc. · Feb 2026
KLS Martin Pure Pectus System
K253660 · KLS-Martin L.P. · Feb 2026