Cleared Traditional

K262649 - Alians Forearm

K262649 is an FDA 510(k) clearance for Alians Forearm, manufactured by Newclip Technics. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262649 · Newclip Technics · Orthopedic device
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Sep 2026
Decision
60d
Days
Class 2
Risk

K262649 is an FDA 510(k) clearance for the Alians Forearm. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on September 28, 2026 after a review of 60 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 Newclip Technics devices

FDA 510(k) Submission Details - K262649

510(k) Number K262649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2026
Decision Date September 28, 2026
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 Consultant

The OrthoMedix Group, Inc.
J.D. Webb

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 1303
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K262649.
TDM Large Bone Plate and Screw System
K261611 · Tdm Co., Ltd. · Oct 2026
ProRib Fixation System
K261892 · Costa Surgical, Inc. · Sep 2026
EnHAnce PEEK Bunion System
K262098 · Nvision Biomedical Technologies · Sep 2026
TMC Implant Fixation System
K262963 · Treace Medical Concepts, Inc. · Sep 2026
Tempo Plating System
K261647 · Pace Surgical · Sep 2026
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · Ortler Global Tibbi Gerecler Anonim Sirketi · Aug 2026