ClearanceBrief
Panels › Orthopedic › Product code HWC · Class 2

Screw, Fixation, Bone

Regulation 888.3040

22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
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Top companies in HWC

Company510(k)sRecalls
Zimmer, Inc.1250
Biomet, Inc.2427
Arthrex, Inc.471
Acumed, LLC535
Depuy Mitek, A Johnson & Johnson Co.1321
Synthes (Usa)313
Smith & Nephew, Inc.276
Smith & Nephew Inc., Endoscopy Division130
Wrightmedicaltechnologyinc310
Stryker Howmedica Osteonics Corp.030
Decided510(k)Device and applicantCode
Jan 14, 2022K203773BRM TOOL Screws
Brm Extremities Srl, IT
HWC
Jan 11, 2022K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
Stryker GmbH
HWC
Jan 4, 2022K203595DynaFuse Fixation System
MedShape, Inc.
HWC
Dec 30, 2021K212547Quick-Start Screws
Innovate Orthopaedics Limited, GB
HWC
Dec 25, 2021K211770R3ACT Stabilization System
Paragon 28, Inc.
HWC
Dec 21, 2021K213596OSSIOfiber Compression Screw, 3.5mm
OSSIO , Ltd., IL
HWC
Dec 21, 2021K213301InCore Subtalar System
Nextremity Solutions, Inc.
HWC
Dec 9, 2021K213530Nextra CH Cannulated Hammertoe System
Nextremity Solutions, Inc.
HWC
Nov 19, 2021K213421Vector® Hammertoe Correction System
Nvision Biomedical Technologies, Inc.
HWC
Nov 16, 2021K212996Sterile PHALINX Hammertoe System
Wrightmedicaltechnologyinc
HWC
Nov 9, 2021K202326BESPA Charcot System
Bespa Global, LLC
HWC
Oct 21, 2021K213036Treace Medical Concepts (TMC) Screw Fixation System
Treace Medical Concepts, Inc.
HWC
Oct 5, 2021K210490ChM 4.5mm Cortical screws
Chm Sp. Z O.O., PL
HWC
Sep 23, 2021K211996Nexta PEEK Hammertoe Correction System
Nextremity Solutions, Inc.
HWC
Aug 25, 2021K210792Auxein Nailing System
Auxein Medical Private Limited, IN
HWC
Aug 20, 2021K203029Auxilock Titanium Interference Screw
Auxein Medical Private Limited, IN
HWC
Aug 6, 2021K211783TriMed Threaded Intramedullary Nail System
TriMed, Inc.
HWC
Aug 6, 2021K211435PAO Cortical Screw
Medacta International S.A., CH
HWC
Aug 3, 2021K211290Cannulated Fasteners and Nuts
OsteoCentric Technologies
HWC
Jul 23, 2021K210159IntraLock System
Fusion Orthopedics, LLC
HWC
Jul 22, 2021K211944Medline UNITE® Digital Fusion Screw System
Medline Industries, Inc.
HWC
Jun 1, 2021K210994Arthrex Beveled FT Screws
Arthrex, Inc.
HWC
May 28, 2021K211261Axis Charcot Fixation System
Extremity Medical, LLC
HWC
May 11, 2021K203228DART-FIRE EDGE Cannulated Screw System
Wright Medical
HWC
Apr 14, 2021K210754Cannulated Fasteners and Nuts
OsteoCentric Technologies
HWC
Feb 26, 2021K210268LTJ Screws and Washer
Azurmeds, Inc.
HWC
Jan 15, 2021K203381Dynanail Mini Hybrid
MedShape, Inc.
HWC
Jan 13, 2021K203105Inion CompressOn Screw
Inion OY, FI
HWC
Jan 5, 2021K193497Fixone Biocomposite Interference Screw
Aju Pharm Co., Ltd., KR
HWC
Dec 30, 2020K203239Arthrex Low Profile Screws
Arthrex, Inc.
HWC
Dec 23, 2020K203467WishBone Medical Plate and Screw System
Wishbone Medical, Inc.
HWC
Dec 16, 2020K200291CREED™ Cannulated Screws
Glw Medical, Inc.
HWC
Nov 13, 2020K203011Monster Screw System
Paragon 28, Inc.
HWC
Nov 6, 2020K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
Medartis AG, CH
HWC
Oct 22, 2020K202817GEO Bone Screw System
Gramercy Extremity Orthopedics, LLC
HWC
Oct 15, 2020K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw System
Osteomed, LLC
HWC
Sep 23, 2020K202569Responsive Arthroscopy Interference Screw System
Responsive Arthroscopy, LLC
HWC
Sep 22, 2020K200987LTJ Screws and Washer
Azurmeds, Inc.
HWC
Aug 4, 2020K201850Vector Hammertoe Correction System
Nvision Biomedical Technologies, Inc.
HWC
Jul 30, 2020K193660OSSIOfiber™ Compression Screws
OSSIO , Ltd., IL
HWC
Jul 16, 2020K201662REDUCT® Headless Compression Screw System
Skeletal Dynamics, Inc.
HWC
Jul 8, 2020K201556Intraosseous Fixation System
Extremity Medical, LLC
HWC
Jun 26, 2020K200840DuoHex CH Cannulated Hammertoe System
Nextremity Solutions, Inc.
HWC
Jun 26, 2020K200226RetroFix
Retrofix Screws, LLC
HWC
Jun 20, 2020K201430InFrame™ Cannulated Fixation System
Exsomed Corp.
HWC
Jun 17, 2020K201319Medline UNITE Jones Fracture Screw System
Medline Industires, Inc.
HWC
May 13, 2020K200124InCore MPJ System
Nextremity Solutions, Inc.
HWC
May 5, 2020K200914Healix Compression Screw System
Nvision Biomedical Technologies, Inc.
HWC
May 4, 2020K200259Headless Compression Screw System
Osteocentric Extremities, LLC
HWC
Apr 18, 2020K191995S4 Screw System
Subchondral Solutions, Inc.
HWC

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