Cleared Special

K254002 - TriMed Volar Bearing Plates (VBEAL-13-7S)

Also marketed or referenced as:
TriMed Volar Bearing Plates (VBEAR-13-7S) TriMed Volar Bearing Plates (VBEAL-14-7S) TriMed Volar Bearing Plates (VBEAR-14-7S) TriMed Volar Bearing Plates (VBEAL-16-7S) TriMed Volar Bearing Plates (VBEAR-16-7S)

K254002 is the FDA 510(k) clearance for TriMed Volar Bearing Plates (VBEAL-13-7S) by TriMed, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 31-day FDA review.

K254002 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
31d
Days
Class 2
Risk

K254002 is an FDA 510(k) clearance for the TriMed Volar Bearing Plates (VBEAL-13-7S). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on January 15, 2026 after a review of 31 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 TriMed, Inc. devices

Submission Details

510(k) Number K254002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date January 15, 2026
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K254002.
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