HRS · Plate, Fixation, Bone

Orthopedic · 21 CFR 888.3030 · Class 2

Overview

Product CodeHRS
Device NamePlate, Fixation, Bone
Regulation21 CFR 888.3030
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Recent Cleared Devices (20 of 1311)

Showing 20 most recent of 1311 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K260761APTUS Clavicle System 2.8Medartis AGJun 5, 2026SESE
K261002Pectus Blu SystemBiomet MicrofixationJun 2, 2026SESE
K261038Xpert PFPNewclip TechnicsMay 29, 2026SESE
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLCMay 9, 2026SESE
K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.Apr 30, 2026SESE
K260411PC Fix SystemChest Wall Innovations, Inc.Apr 24, 2026SESE
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AGApr 24, 2026SESE
K260054I.T.S. PRS Phoenix III.T.S. GmbHApr 24, 2026SESE
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.Apr 10, 2026SESE
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.Apr 1, 2026SESE
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.Mar 25, 2026SESE
K260274Airlock® Ankle Plating SystemNovastep SASMar 25, 2026SESE
K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AGMar 24, 2026SESE
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.Mar 23, 2026SESE
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.Mar 19, 2026SESE
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.Mar 17, 2026SESE
K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.Mar 17, 2026SESE
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AGMar 16, 2026SESE
K253906Xpert HandNewclip TechnicsMar 11, 2026SESE
K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbHMar 9, 2026SESE

Top Applicants

Innolitics

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