Cleared Abbreviated

Avanti Distal Elbow ORIF System (K261145) - FDA 510(k) Clearance

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

K261145 · Avanti Orthopaedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
32d
Days
Class 2
Risk

K261145 is an FDA 510(k) clearance for the Avanti Distal Elbow ORIF 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 Avanti Orthopaedics, LLC (Wilmington, US). The FDA issued a Cleared decision on May 9, 2026 after a review of 32 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Avanti Orthopaedics, LLC devices

Submission Details

510(k) Number K261145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2026
Decision Date May 09, 2026
Days to Decision 32 days
Submission Type Abbreviated
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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Secure BioMed Evaluations
Justin Gracyalny

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1310
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K261145.
APTUS Clavicle System 2.8
K260761 · Medartis AG · Jun 2026
Pectus Blu System
K261002 · Biomet Microfixation · Jun 2026
Xpert PFP
K261038 · Newclip Technics · May 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · OrthoPediatrics Corp. · Apr 2026
PC Fix System
K260411 · Chest Wall Innovations, Inc. · Apr 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · Bonebridge AG · Apr 2026