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Screw, Fixation, Bone

FDA product code HWC · 996 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3040
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-01-14 – 2026-09-25

HWC 2022-01-04

DynaFuse Fixation System

Applicant MedShape, Inc.

K number K203595

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HWC 2021-12-30

Quick-Start Screws

Applicant Innovate Orthopaedics Limited

K number K212547

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HWC 2021-12-25

R3ACT Stabilization System

Applicant Paragon 28, Inc.

K number K211770

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HWC 2021-12-21

OSSIOfiber Compression Screw, 3.5mm

Applicant OSSIO , Ltd.

K number K213596

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HWC 2021-12-21

InCore Subtalar System

Applicant Nextremity Solutions, Inc.

K number K213301

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HWC 2021-12-09

Nextra CH Cannulated Hammertoe System

Applicant Nextremity Solutions, Inc.

K number K213530

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HWC 2021-11-19

Vector® Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K number K213421

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HWC 2021-11-16

Sterile PHALINX Hammertoe System

Applicant Wrightmedicaltechnologyinc

K number K212996

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HWC 2021-11-09

BESPA Charcot System

Applicant Bespa Global, LLC

K number K202326

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HWC 2021-10-21

Treace Medical Concepts (TMC) Screw Fixation System

Applicant Treace Medical Concepts, Inc.

K number K213036

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HWC 2021-10-05

ChM 4.5mm Cortical screws

Applicant Chm Sp. Z O.O.

K number K210490

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HWC 2021-09-23

Nexta PEEK Hammertoe Correction System

Applicant Nextremity Solutions, Inc.

K number K211996

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HWC 2021-08-25

Auxein Nailing System

Applicant Auxein Medical Private Limited

K number K210792

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HWC 2021-08-20

Auxilock Titanium Interference Screw

Applicant Auxein Medical Private Limited

K number K203029

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HWC 2021-08-06

TriMed Threaded Intramedullary Nail System

Applicant TriMed, Inc.

K number K211783

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HWC 2021-08-06

PAO Cortical Screw

Applicant Medacta International S.A.

K number K211435

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HWC 2021-08-03

Cannulated Fasteners and Nuts

Applicant OsteoCentric Technologies

K number K211290

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HWC 2021-07-23

IntraLock System

Applicant Fusion Orthopedics, LLC

K number K210159

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HWC 2021-07-22

Medline UNITE® Digital Fusion Screw System

Applicant Medline Industries, Inc.

K number K211944

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HWC 2021-06-01

Arthrex Beveled FT Screws

Applicant Arthrex, Inc.

K number K210994

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HWC 2021-05-28

Axis Charcot Fixation System

Applicant Extremity Medical, LLC

K number K211261

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HWC 2021-05-11

DART-FIRE EDGE Cannulated Screw System

Applicant Wright Medical

K number K203228

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HWC 2021-04-14

Cannulated Fasteners and Nuts

Applicant OsteoCentric Technologies

K number K210754

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HWC 2021-02-26

LTJ Screws and Washer

Applicant Azurmeds, Inc.

K number K210268

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HWC 2021-01-15

Dynanail Mini Hybrid

Applicant MedShape, Inc.

K number K203381

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HWC 2021-01-13

Inion CompressOn Screw

Applicant Inion OY

K number K203105

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HWC 2021-01-05

Fixone Biocomposite Interference Screw

Applicant Aju Pharm Co., Ltd.

K number K193497

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HWC 2020-12-30

Arthrex Low Profile Screws

Applicant Arthrex, Inc.

K number K203239

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HWC 2020-12-23

WishBone Medical Plate and Screw System

Applicant Wishbone Medical, Inc.

K number K203467

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HWC 2020-12-16

CREED™ Cannulated Screws

Applicant Glw Medical, Inc.

K number K200291

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HWC 2020-11-13

Monster Screw System

Applicant Paragon 28, Inc.

K number K203011

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HWC 2020-11-06

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System

Applicant Medartis AG

K number K202589

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HWC 2020-10-22

GEO Bone Screw System

Applicant Gramercy Extremity Orthopedics, LLC

K number K202817

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HWC 2020-10-15

OsteoMed ExtremiFix Mini & Small Cannulated Screw System

Applicant Osteomed, LLC

K number K202680

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HWC 2020-09-23

Responsive Arthroscopy Interference Screw System

Applicant Responsive Arthroscopy, LLC

K number K202569

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HWC 2020-09-22

LTJ Screws and Washer

Applicant Azurmeds, Inc.

K number K200987

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HWC 2020-08-04

Vector Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K number K201850

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HWC 2020-07-30

OSSIOfiber™ Compression Screws

Applicant OSSIO , Ltd.

K number K193660

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HWC 2020-07-16

REDUCT® Headless Compression Screw System

Applicant Skeletal Dynamics, Inc.

K number K201662

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HWC 2020-07-08

Intraosseous Fixation System

Applicant Extremity Medical, LLC

K number K201556

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HWC 2020-06-26

DuoHex CH Cannulated Hammertoe System

Applicant Nextremity Solutions, Inc.

K number K200840

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HWC 2020-06-26

RetroFix

Applicant Retrofix Screws, LLC

K number K200226

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HWC 2020-06-20

InFrame™ Cannulated Fixation System

Applicant Exsomed Corp.

K number K201430

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HWC 2020-06-17

Medline UNITE Jones Fracture Screw System

Applicant Medline Industires, Inc.

K number K201319

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HWC 2020-05-13

InCore MPJ System

Applicant Nextremity Solutions, Inc.

K number K200124

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HWC 2020-05-05

Healix Compression Screw System

Applicant Nvision Biomedical Technologies, Inc.

K number K200914

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HWC 2020-05-04

Headless Compression Screw System

Applicant Osteocentric Extremities, LLC

K number K200259

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HWC 2020-04-18

S4 Screw System

Applicant Subchondral Solutions, Inc.

K number K191995

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HWC 2020-03-20

T2 ICF

Applicant Stryker GmbH

K number K193366

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HWC 2020-03-19

restor3d Metallic Interference Screw

Applicant Restor3D

K number K193491

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HWC 2020-02-27

Omnia Medical Trauma Screws

Applicant Omnia Medical, LLC

K number K192096

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HWC 2020-02-24

Titanium Interference Screws

Applicant Biomet, Inc.

K number K193451

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HWC 2020-02-10

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws

Applicant Arthrex, Inc.

K number K193156

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HWC 2020-01-09

Tyber Medical Trauma Screws

Applicant Tyber Medical, LLC

K number K192975

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HWC 2020-01-08

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K number K192974

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HWC 2019-12-31

InCore TMT System

Applicant Nextremity Solutions, Inc.

K number K192578

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HWC 2019-11-26

DePuy Synthes Trauma Screws

Applicant Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K number K192745

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HWC 2019-11-26

ARIX Cannulated Screw System

Applicant Jeil Medical Corporation

K number K192417

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HWC 2019-11-06

Arthrex Nano SwiveLock Suture Anchor

Applicant Arthrex, Inc.

K number K191651

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HWC 2019-10-30

Arthrex Low Profile Screws

Applicant Arthrex, Inc.

K number K190921

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HWC 2019-10-16

SECURE Screw

Applicant A.M. Surgical, Inc.

K number K191771

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HWC 2019-09-13

TDM Screw Systems

Applicant Tdm Co., Ltd.

K number K190830

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HWC 2019-08-28

Interphalangeal Joint Fusion Device Range

Applicant Neosteo

K number K191424

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HWC 2019-08-19

CrossRoads Screw System

Applicant Crossroads Extemity Systems, LLC

K number K191342

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HWC 2019-08-13

PROSTEP™ TBI™ (Tailors Bunion Implant) System

Applicant Wrightmedicaltechnologyinc

K number K190970

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HWC 2019-07-29

Bone Screw Line Addition

Applicant Vilex IN Tennessee, Inc.

K number K191289

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HWC 2019-07-26

ActivOrtho Continuous Compression Screw System

Applicant Activortho, Inc.

K number K191817

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HWC 2019-07-05

OrthoPediatrics Cannulated Screw System

Applicant OrthoPediatrics Corp.

K number K190324

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HWC 2019-06-13

Treace Medical Concepts (TMC) Snap-Off Screw System

Applicant Treace Medical Concepts, Inc.

K number K183363

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HWC 2019-06-10

Mini Cannulated Headed and Headless Screw Set

Applicant Stryker GmbH

K number K183104

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HWC 2019-05-24

InCore® Lapidus Sterile Kits

Applicant Nextremity Solutions, Inc.

K number K190231

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HWC 2019-05-21

IntraLock Lapidus System

Applicant Fusion Orthopedics, LLC

K number K182342

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HWC 2019-04-17

Arthrex 2.5 mm Tenodesis Screw

Applicant Arthrex, Inc.

K number K183395

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HWC 2019-04-03

Monster® Screw System

Applicant Paragon 28, Inc.

K number K190586

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HWC 2019-03-26

Arthrex TensionLoc System

Applicant Arthrex, Inc.

K number K183628

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HWC 2019-03-22

OsteoCentric Bone Plate and Screw System

Applicant Osteocentric Trauma

K number K190430

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HWC 2019-03-13

Wright Jones Fracture System

Applicant Wrightmedicaltechnologyinc

K number K183026

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HWC 2019-03-12

INnate Cannulated Screw System

Applicant Exsomed Corporation

K number K183603

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HWC 2019-03-12

ActivOrtho Nitinol Compression Screw System

Applicant Activortho, Inc.

K number K181610

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HWC 2019-03-01

CurvaFix Intramedullary Rodscrew System

Applicant Curvafix, Inc.

K number K180050

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HWC 2019-02-19

Vector Hammertoe Correction System

Applicant Nvision Biomedical Technologies, LLC

K number K183055

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HWC 2019-02-14

DynaNail Mini

Applicant MedShape, Inc.

K number K182677

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HWC 2019-02-07

Biomet Headless Compression and Twist-Off Screws

Applicant Biomet, Inc.

K number K190035

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HWC 2019-01-22

EZStart Interference Screw

Applicant Conmed Corporation

K number K182955

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HWC 2019-01-11

PROSTEP MICA Screw System

Applicant Wrightmedicaltechnologyinc

K number K181377

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HWC 2018-12-18

AURORA™ Screw System

Applicant MiRus, LLC

K number K182989

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HWC 2018-12-18

Arthrex Compression FT Screws

Applicant Arthrex, Inc.

K number K182361

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HWC 2018-12-07

ICONN Campbell Interference Screw

Applicant Iconn Orthopedics, LLC

K number K180670

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HWC 2018-12-04

Healix™ Compression Screw System

Applicant Nvision Biomedical Technologies, LLC

K number K182949

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HWC 2018-11-23

HammerTechTM Fixation System

Applicant Fusion Orthopedics, LLC

K number K182684

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HWC 2018-11-23

Responsive Arthroscopy Interference Screw System

Applicant Responsive Arthroscopy, LLC

K number K180573

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HWC 2018-11-21

DePuy Synthes 2.0 mm Quick Insertion Screws

Applicant Synthes USA Products, LLC

K number K180541

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HWC 2018-10-26

Two-Step Implant System

Applicant Trilliant Surgical

K number K181898

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HWC 2018-09-07

SILVERBACK Gorilla Plating System

Applicant Paragon 28, Inc.

K number K182148

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HWC 2018-07-17

Field Orthopaedics Micro Screw System

Applicant Field Orthopaedics Pty, Ltd.

K number K180348

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HWC 2018-07-13

Injection Screw

Applicant Biedermann Medtech, Inc.

K number K173556

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HWC 2018-07-11

SALVATION Midfoot Nail

Applicant Wrightmedicaltechnologyinc

K number K180024

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HWC 2018-06-20

Fracture and Correction System

Applicant In2bones USA, LLC

K number K180377

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HWC 2018-06-04

VariAx 2 System

Applicant Stryker GmbH

K number K180500

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HWC 2018-05-09

Diamond Orthopedic Bone Fixation Screws and Pins

Applicant Diamond Orthopedic, LLC

K number K180932

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