ClearanceBrief
Panels › Orthopedic › Product code HRS · Class 2

Plate, Fixation, Bone

Regulation 888.3030

62510(k)s in 12 months (1,332 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
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Top companies in HRS

Company510(k)sRecalls
Synthes1048
Smith & Nephew3716
Biomet2128
Wrightmedicaltechnologyinc450
Zimmer GmbH3212
Wright Medical Technology Inc043
Arthrex, Inc.393
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Jan 12, 2026K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
Arthrex, Inc.
HRS
Jan 6, 2026K253178TRILEAP Plating System
Crossroads Extremity Systems
HRS
Dec 19, 2025K251050Pectus Versa System
Gm Dos Reis Industria E Comercio, BR
HRS
Dec 17, 2025K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
Bonebridge AG, CH
HRS
Dec 11, 2025K252997HyperFlex® Bunion Correction System
Hyperflex Medical
HRS
Dec 11, 2025K252897APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Lo
A Plus Biotechnology Co., Ltd., TW
HRS
Dec 11, 2025K250988KLS Martin Pure Pectus System
KLS-Martin L.P.
HRS
Nov 19, 2025K252661SternaFuse Ti Fixation System
Fusion Innovations, LLC
HRS
Nov 18, 2025K253423ToeJack MIS Bunion System
Nvision Biomedical Technologies, Inc.
HRS
Nov 14, 2025K250865KLS Martin IPS Forearm System
KLS-Martin L.P.
HRS
Nov 13, 2025K252949Geminus Volar Distal Radius Plating System
Skeletal Dynamics, Inc.
HRS
Nov 12, 2025K252959WRISTAR MultiAx Distal Radius Kit
Intrauma S.P.A, IT
HRS
Oct 28, 2025K253300Fine Osteotomy™
Bodycad Laboratories, Inc., CA
HRS
Oct 9, 2025K252600Pediatric Plating Platform I Small-Mini
OrthoPediatrics Corp.
HRS
Sep 8, 2025K251892MAXXOS P.A.C.E. Foot & Ankle Plating System
Maxxos Medical GmbH, DE
HRS
Aug 21, 2025K252356The Acumed Wrist Fixation System - 2.4mm Screws
Acumed, LLC
HRS
Aug 21, 2025K251135Treace Medical Concepts (TMC) Implant Fixation System
Treace Medical Concepts
HRS
Aug 21, 2025K250923Fine Osteotomy™
Bodycad Laboratories, Inc., CA
HRS
Aug 20, 2025K252061Distal Xtremities System
TriMed, Inc.
HRS
Aug 18, 2025K251161ANTHEM® Fracture System
Globus Medical, Inc.
HRS
Aug 16, 2025K251913OsteoCentric® UnifiMI® TCS Plating System
OsteoCentric Technologies
HRS
Aug 15, 2025K250620KLS Martin Ixos System
KLS Martin L.P.
HRS
Jul 30, 2025K251361Tyber Medical Distal Radius Plating System
Tyber Medical, LLC
HRS
Jul 25, 2025K251620A.L.P.S. Proximal Humerus Plating System
Zimmer Biomet
HRS
Jul 18, 2025K250952Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.
HRS
Jul 14, 2025K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
Acumed, LLC
HRS
Jul 10, 2025K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
TriMed, Inc.
HRS
Jun 27, 2025K242988Genostis Osteosynthesis System
Genostis AF, CH
HRS
Jun 26, 2025K250929TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2
TriMed, Inc.
HRS
Jun 26, 2025K243275Equinoxe® Scapula Fracture System
Exactech, Inc.
HRS
Jun 18, 2025K251296The Acumed Wrist Fixation System
Acumed, LLC
HRS
Jun 11, 2025K250933LORRAINE 2.5/3.5mm Distal Humerus System
Bonebridge AG, CH
HRS
Jun 4, 2025K243368Montblanc Plate System
Medifield Medical Co., Ltd., KR
HRS
May 30, 2025K242751ARIX Pectus Bar System
Jeil Medical Corporation, KR
HRS
May 29, 2025K243469SIGNEX
Osteonic Co., Ltd., KR
HRS
May 22, 2025K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
TriMed, Inc.
HRS
Apr 29, 2025K243963Pediatric Plating Platform Hip
OrthoPediatrics Corp.
HRS
Apr 25, 2025K250892CastleLoc Pectus Bar System
L&K BIOMED Co., Ltd., KR
HRS
Apr 24, 2025K242973CanMINI Hand and Foot System
Canwell Medical Co., Ltd., CN
HRS
Apr 23, 2025K250155Xpert Knee
Newclip Technics, FR
HRS
Apr 8, 2025K250948TriMed Fusion Cup System
TriMed, Inc.
HRS
Mar 26, 2025K243995Arthrex Humeral Plating System and Cerclage Button
Arthrex, Inc.
HRS
Mar 19, 2025K243999TriMed Ankle Fixation System
TriMed, Inc.
HRS
Mar 19, 2025K243987TriMed Elbow and Forearm System
TriMed, Inc.
HRS
Mar 19, 2025K242486Tyber Medical Anatomical Plating System
Tyber Medical, LLC
HRS
Mar 18, 2025K250494The OsteoCentric Bone Plate and Screw System
OsteoCentric Technologies
HRS
Mar 17, 2025K250498BPS Wrist Fracture System
Orthonovis, Inc.
HRS
Mar 7, 2025K243610APTUS Hand System; APTUS Elbow Dorsal Olecranon
Medartis AG, CH
HRS
Feb 27, 2025K243357CastleLoc Pectus Bar System
L&K BIOMED Co., Ltd., KR
HRS
Feb 19, 2025K243761A.L.P.S. Small Fragment Plating System
Biomet Orthopedics
HRS

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