Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2026-09-25

Arthrex Beaming System

Applicant Arthrex, Inc.

K number K262975

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HWC 2026-09-23

DynaNail Helix® Fixation System

Applicant MedShape, Inc.

K number K260995

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HWC 2026-09-21

F.A.S.T Screw

Applicant Steps Ortho

K number K254280

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HWC 2026-09-04

ActivaScrew™ Cannulated COM

Applicant Bioretec, Ltd.

K number K261057

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HWC 2026-08-24

OsteoCoil™ GT Active Compression System

Applicant Flower Orthopedics Corporation DBA Conventus Flower Orthoped

K number K260106

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HWC 2026-08-12

Large Compression Screws

Applicant TriMed, Inc.

K number K262344

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HWC 2026-08-05

GFS - Sterile Screws and Top Hat

Applicant T.A.G. Medical Products Corporation, Ltd.

K number K253858

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HWC 2026-07-22

Lapidus Screw Kit

Applicant Relja Innovations, LLC

K number K262075

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HWC 2026-06-25

Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System

Applicant Arthrex, Inc.

K number K260809

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HWC 2026-06-05

VEOFIX Snap Off Screw

Applicant Steps Ortho

K number K253108

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HWC 2026-05-30

CoLink® & CoLag® Non-Sterile Screws

Applicant In2Bones USA, LLC

K number K261154

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HWC 2026-05-14

TriMed Compression Screws

Applicant TriMed, Inc.

K number K261241

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HWC 2026-05-08

Arthrex Beaming System

Applicant Arthrex, Inc.

K number K254215

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HWC 2026-05-01

OSSIOfiber® Threaded Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K number K254077

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HWC 2026-04-17

TITAN Nail; APTUS K-Wire System

Applicant Medartis AG

K number K260934

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HWC 2026-04-10

CoAptix S System

Applicant University of Utah, Department of Orthopaedics

K number K252699

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HWC 2026-04-03

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K number K253042

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HWC 2026-03-18

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro

Applicant MedShape, Inc.

K number K254110

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HWC 2026-03-06

Treace Medical Concepts (TMC) Screw Fixation System

Applicant Treace Medical Concepts, Inc.

K number K260361

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HWC 2025-12-31

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K number K252901

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HWC 2025-11-06

Ultra™ Compression Screw System

Applicant Pace Surgical

K number K251555

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HWC 2025-10-10

Eleganz IM Threaded Nail System (IM Threaded Nail System)

Applicant Dev4

K number K252312

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HWC 2025-10-08

MetaFore Small Screw System

Applicant Extremity Medical, LLC

K number K250536

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HWC 2025-10-02

Cannulated Screw and Kirschner (K wire) System

Applicant Orthonovis, Inc.

K number K252758

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HWC 2025-08-29

CurvaFix Low Profile System

Applicant Curvafix, Inc.

K number K252019

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HWC 2025-08-27

Phoenix Sinus Tarsi Stent System

Applicant Astra Orthomed, Inc.

K number K251382

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HWC 2025-08-15

Dunamis Screw and Suture Locking System

Applicant Dunamis Medical, LLC

K number K250867

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HWC 2025-06-13

Eleganz Fusion Screw System (Fusion Screw System)

Applicant Dev4

K number K250251

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HWC 2025-04-10

TriMed® Compression Screws

Applicant TriMed, Inc.

K number K243943

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HWC 2025-04-02

SnapHammer Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K number K250613

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HWC 2025-03-05

TITANEX Screw Systems

Applicant Vilex, LLC

K number K250304

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HWC 2025-02-05

Caliber Intramedullary Fixation System

Applicant Nvision Biomedical Technologies

K number K242896

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HWC 2025-01-31

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

Applicant Innovate Orthopaedics, Ltd.

K number K242442

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HWC 2025-01-10

Arthrex SS VAL and VAL KreuLock™ Compression Screw System

Applicant Arthrex, Inc.

K number K243195

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HWC 2024-12-04

Locking Screw,CoCrMo

Applicant Double Medical Technology, Inc.

K number K242348

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HWC 2024-11-22

OsteoCoil™ Nitinol Compression System (Multiple Component PNs)

Applicant Flower Orthopedics Corporation Dba Conventus Flower Ortho

K number K233567

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HWC 2024-10-29

Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

Applicant Tigon Medical

K number K240175

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HWC 2024-10-09

OsteoCentric Technologies Cannulated Fasteners and Nuts

Applicant OsteoCentric Technologies

K number K242691

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HWC 2024-10-04

Treace Medical Concepts (TMC) Screw Fixation System

Applicant Treace Medical Concepts, Inc.

K number K242671

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HWC 2024-08-31

Arthrex VAL and VAL KreuLock™ Compression Screw System

Applicant Arthrex, Inc.

K number K241592

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HWC 2024-08-02

Medline UNITE® MIS Foot Recon Screw System

Applicant Medline Industries, LP

K number K241359

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HWC 2024-07-03

OSSIOfiber® Threaded Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K number K241277

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HWC 2024-06-13

Arthrex Cannulated Screw System

Applicant Arthrex, Inc.

K number K240815

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HWC 2024-06-05

Cannulated Headless Bone Screws

Applicant Aap Implantate AG

K number K233008

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HWC 2024-03-21

DynaNail Mini Tapered Hybrid

Applicant MedShape, Inc.

K number K240530

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HWC 2024-03-11

ARIX Cannulated Screw System

Applicant Jeil Medical Corporation

K number K233912

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HWC 2024-03-08

OSSIOfiber® Threaded Trimmable Fixation Nails

Applicant OSSIO , Ltd.

K number K233198

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HWC 2024-02-16

SnapHammer Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K number K231453

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HWC 2024-01-18

TriMed Threaded Intramedullary Nail System

Applicant TriMed, Inc.

K number K234040

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HWC 2024-01-18

TDM Screw System

Applicant Tdm Co., Ltd.

K number K231860

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HWC 2024-01-04

Zimed Distal Medial Tibial Plate and Screw System

Applicant Zimed Medikal

K number K230507

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HWC 2023-12-21

Cannulated Screw System

Applicant Smith & Nephew, Inc.

K number K233396

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HWC 2023-11-03

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension

Applicant Medartis AG

K number K232251

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HWC 2023-10-12

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices

Applicant Paragon 28, Inc.

K number K231231

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HWC 2023-09-29

Intraosseous Fusion Device System

Applicant Auxano Medical, LLC

K number K231649

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HWC 2023-09-15

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L

Applicant Trax Surgical

K number K230946

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HWC 2023-09-11

TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System

Applicant Vilex, LLC

K number K231504

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HWC 2023-09-05

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

Applicant Innovate Orthopaedics Limited

K number K231819

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HWC 2023-08-30

Nexis® compressive screws

Applicant Novastep

K number K223468

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HWC 2023-07-27

IBS-B MIS Beveled Screw System

Applicant In2bones USA, LLC

K number K231236

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HWC 2023-07-18

Forma Medical Headless Compression Screw

Applicant Forma Medical, Inc.

K number K230945

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HWC 2023-06-29

OsteoCentric ACL Fixation System

Applicant OsteoCentric Technologies

K number K230595

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HWC 2023-06-26

Bone Bolt System

Applicant University of Utah, Department of Orthopaedics

K number K230867

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HWC 2023-06-12

Cut Screw - Percutaneous Compression Screw

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K230397

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HWC 2023-06-09

Acumed Acutrak 3 Headless Compression Screw System

Applicant Acumed, LLC

K number K230744

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HWC 2023-04-28

Hand Trauma Threaded Nail System

Applicant Skeletal Dynamics, Inc.

K number K230908

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HWC 2023-04-19

SimpliFix Hip System

Applicant Stabiliz Orthopaedics, Inc.

K number K230053

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HWC 2023-04-17

TriMed Threaded Intramedullary Nail System

Applicant TriMed, Inc.

K number K230749

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HWC 2023-02-28

REVCON (TM) Screw System

Applicant Voom Medical Devices, Inc.

K number K223392

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HWC 2023-02-17

PROstep(TM) MIS 5mm Chamfer Screw System

Applicant Wright Medical Technology

K number K221645

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HWC 2023-02-16

Bony Trauma Extremity System (BTES) Screw Range, NX Nail

Applicant Field Orthopaedics Pty, Ltd.

K number K230118

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HWC 2023-02-13

OIC Intramedullary Screw System

Applicant Orthopaedic Implant Company

K number K223761

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HWC 2023-01-25

CREED™ Cannulated Screws

Applicant Glw, Inc.

K number K223847

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HWC 2023-01-10

Haymaker® Screw System

Applicant Orthocircle Spine D.B.A. OC Medical Devices

K number K222799

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HWC 2023-01-10

Metal Cannulated Screw

Applicant Double Medical Technology, Inc.

K number K221090

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HWC 2022-12-29

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

Applicant Acumed, LLC

K number K221333

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HWC 2022-12-23

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm

Applicant OSSIO , Ltd.

K number K221193

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HWC 2022-12-16

Phantom Metatarsal Shortening System

Applicant Paragon 28, Inc.

K number K223184

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HWC 2022-12-16

BRM TOOL Screws, BIOPLAN Subtalar Implant

Applicant Brm Extremities

K number K222820

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HWC 2022-12-13

REDEMPTION Beaming System

Applicant Vilex, LLC

K number K221342

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HWC 2022-12-12

Metal Bone Screw

Applicant Double Medical Technology, Inc.

K number K220921

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HWC 2022-11-23

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

Applicant Avanti Orthopaedics, Inc.

K number K222967

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HWC 2022-11-15

Treace Medical Concepts (TMC) Hammertoe Fixation System

Applicant Treace Medical Concepts, Inc.

K number K222564

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HWC 2022-11-04

Nextra CH Cannulated Hammertoe System

Applicant Nextremity Solutions, Inc.

K number K221610

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HWC 2022-10-27

CurvaFix IM System

Applicant Curvafix, Inc.

K number K222505

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HWC 2022-09-20

Tandry Compression Screw System

Applicant Microware Precision Co., Ltd.

K number K220359

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HWC 2022-09-19

Arthrex Compression FT Pins

Applicant Arthrex, Inc.

K number K220839

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HWC 2022-09-08

CAPTIVATE® Compression Screws

Applicant Globus Medical, Inc.

K number K222409

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HWC 2022-08-03

Cannulated Screws

Applicant Maxxion Medical, LLC

K number K213614

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HWC 2022-06-10

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System

Applicant Stryker GmbH

K number K220319

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HWC 2022-05-12

Hand Trauma Screw System

Applicant Skeletal Dynamics, Inc.

K number K220723

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HWC 2022-04-27

ExsoMed INnate NanoTM Lag Screw System

Applicant Exsomed Corp.

K number K220892

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HWC 2022-04-13

Cannulated Compression Device System

Applicant Orthopedic Designs North America, Inc.

K number K210146

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HWC 2022-03-22

Medline UNITE IM Fibula Implant

Applicant Medline Industries, LP

K number K220511

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HWC 2022-03-10

SIGNUS SACRONAIL® Transsacral Stabilization System

Applicant Signus Medizintechnik GmbH

K number K212755

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HWC 2022-02-03

MectaScrew Extension

Applicant Medacta International S.A.

K number K203335

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HWC 2022-01-31

MIS Precision Chevron Bunion System

Applicant Relja Innovations, LLC

K number K211628

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HWC 2022-01-18

JuniOrtho Plating System™

Applicant Orthofix Srl

K number K213572

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HWC 2022-01-14

BRM TOOL Screws

Applicant Brm Extremities Srl

K number K203773

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HWC 2022-01-11

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System

Applicant Stryker GmbH

K number K213199

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