Alians Elbow S

FDA 510(k) K261191 · Newclip Technics

Substantially Equivalent

510(k) numberK261191

Submission

Device name
Alians Elbow S
Applicant
Newclip Technics
Haute-Goulaine, FR
Received
April 13, 2026
Decision date
July 8, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HRS – Plate, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HRS

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K261647Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional Pace Surgical09/03/2026SE
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional Ortler Global Tibbi Gerecler Anonim Sirketi08/28/2026SE
K262537Versalock Sterile Plating SystemHRS · Special GM Dos Reis Industria e Comercio Ltda.08/19/2026SE
K260277Mikron Trauma Bone Plate& Screw SystemHRS · Traditional Mikron Makina San. ve Tic. Ltd. Sti.08/13/2026SE
K261511Xpert AnkleHRS · Traditional Newclip Technics07/28/2026SE
K261406Versalock Proximal Tibial Plating SystemHRS · Traditional GM Dos Reis Industria e Comercio Ltda.07/21/2026SE
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special TriMed, Inc.07/16/2026SE
K261054RibPlate SystemHRS · Traditional Stryker Leibinger GmbH & Co KG07/01/2026SE
K261351SALGINA 2.5mm Distal Radius SystemHRS · Traditional Bonebridge AG06/26/2026SE
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…HRS · Traditional I.T.S. GmbH06/16/2026SE

More from I.T.S. GmbH

510(k)DeviceDecision
K261511Xpert AnkleHRS · Traditional 07/28/2026SE
K261038Xpert PFPHRS · Traditional 05/29/2026SE
K253906Xpert HandHRS · Traditional 03/11/2026SE
K250767Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional 10/01/2025SE
K250155Xpert KneeHRS · Traditional 04/23/2025SE
K243912Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional 02/13/2025SE
K240415Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional 11/07/2024SE
K241539Activmotion SHRS · Traditional 07/30/2024SE
K221615Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional 10/25/2023SE
K221395Footmotion Plating SystemHRS · Traditional 07/01/2022SE

Questions and answers

When was Alians Elbow S cleared by the FDA?

Alians Elbow S (K261191) received a 510(k) decision of Substantially Equivalent on July 8, 2026, 86 days after the submission was received.

What is the product code of K261191?

The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.