Atlas FDA

HWC

1,062 FDA 510(k) clearances · Product code

88 daysmedian time to decision
247 days90th percentile
1,062clearances measured

FDA profile

Official device name
Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 4,446 · 2022: 3,934 · 2023: 3,717 · 2024: 3,575 · 2025: 2,930 · 2026: 2,128
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
GFS - Sterile Screws and Top Hat (K253858)T.A.G. Medical Products Corporation, Ltd.2026-08-05
Lapidus Screw Kit (K262075)Relja Innovations, LLC2026-07-22
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (K260809)Arthrex, Inc.2026-06-25
VEOFIX Snap Off Screw (K253108)Steps Ortho2026-06-05
CoLink® & CoLag® Non-Sterile Screws (K261154)In2Bones USA, LLC2026-05-30
TriMed Compression Screws (K261241)TriMed, Inc.2026-05-14
Arthrex Beaming System (K254215)Arthrex, Inc.2026-05-08
OSSIOfiber® Threaded Trimmable Fixation Nail (K254077)OSSIO , Ltd.2026-05-01
TITAN Nail; APTUS K-Wire System (K260934)Medartis AG2026-04-17
CoAptix S System (K252699)University of Utah, Department of Orthopaedics2026-04-10
Tyber Medical Trauma Screw (K253042)Tyber Medical, LLC2026-04-03
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (K254110)MedShape, Inc.2026-03-18
Treace Medical Concepts (TMC) Screw Fixation System (K260361)Treace Medical Concepts, Inc.2026-03-06
Tyber Medical Trauma Screw (K252901)Tyber Medical, LLC2025-12-31
Ultra™ Compression Screw System (K251555)Pace Surgical2025-11-06
Eleganz IM Threaded Nail System (IM Threaded Nail System) (K252312)Dev42025-10-10
MetaFore Small Screw System (K250536)Extremity Medical, LLC2025-10-08
Cannulated Screw and Kirschner (K wire) System (K252758)Orthonovis, Inc.2025-10-02
CurvaFix Low Profile System (K252019)Curvafix, Inc.2025-08-29
Phoenix Sinus Tarsi Stent System (K251382)Astra Orthomed, Inc.2025-08-27
Dunamis Screw and Suture Locking System (K250867)Dunamis Medical, LLC2025-08-15
Eleganz Fusion Screw System (Fusion Screw System) (K250251)Dev42025-06-13
TriMed® Compression Screws (K243943)TriMed, Inc.2025-04-10
SnapHammer Hammertoe Correction System (K250613)Nvision Biomedical Technologies, Inc.2025-04-02
TITANEX Screw Systems (K250304)Vilex, LLC2025-03-05
Caliber Intramedullary Fixation System (K242896)Nvision Biomedical Technologies2025-02-05
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K242442)Innovate Orthopaedics, Ltd.2025-01-31
Arthrex SS VAL and VAL KreuLock™ Compression Screw System (K243195)Arthrex, Inc.2025-01-10
Locking Screw,CoCrMo (K242348)Double Medical Technology, Inc.2024-12-04
OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (K233567)Flower Orthopedics Corporation Dba Conventus Flower Ortho2024-11-22
Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (K240175)Tigon Medical2024-10-29
OsteoCentric Technologies Cannulated Fasteners and Nuts (K242691)OsteoCentric Technologies2024-10-09
Treace Medical Concepts (TMC) Screw Fixation System (K242671)Treace Medical Concepts, Inc.2024-10-04
Arthrex VAL and VAL KreuLock™ Compression Screw System (K241592)Arthrex, Inc.2024-08-31
Medline UNITE® MIS Foot Recon Screw System (K241359)Medline Industries, LP2024-08-02
OSSIOfiber® Threaded Trimmable Fixation Nail (K241277)OSSIO , Ltd.2024-07-03
Arthrex Cannulated Screw System (K240815)Arthrex, Inc.2024-06-13
Cannulated Headless Bone Screws (K233008)Aap Implantate AG2024-06-05
DynaNail Mini Tapered Hybrid (K240530)MedShape, Inc.2024-03-21
ARIX Cannulated Screw System (K233912)Jeil Medical Corporation2024-03-11
OSSIOfiber® Threaded Trimmable Fixation Nails (K233198)OSSIO , Ltd.2024-03-08
SnapHammer Hammertoe Correction System (K231453)Nvision Biomedical Technologies, Inc.2024-02-16
TriMed Threaded Intramedullary Nail System (K234040)TriMed, Inc.2024-01-18
TDM Screw System (K231860)Tdm Co., Ltd.2024-01-18
Zimed Distal Medial Tibial Plate and Screw System (K230507)Zimed Medikal2024-01-04
Cannulated Screw System (K233396)Smith & Nephew, Inc.2023-12-21
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (K232251)Medartis AG2023-11-03
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (K231231)Paragon 28, Inc.2023-10-12
Intraosseous Fusion Device System (K231649)Auxano Medical, LLC2023-09-29
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 (K230946)Trax Surgical2023-09-15
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System (K231504)Vilex, LLC2023-09-11
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K231819)Innovate Orthopaedics Limited2023-09-05
Nexis® compressive screws (K223468)Novastep2023-08-30
IBS-B MIS Beveled Screw System (K231236)In2bones USA, LLC2023-07-27
Forma Medical Headless Compression Screw (K230945)Forma Medical, Inc.2023-07-18
OsteoCentric ACL Fixation System (K230595)OsteoCentric Technologies2023-06-29
Bone Bolt System (K230867)University of Utah, Department of Orthopaedics2023-06-26
Cut Screw - Percutaneous Compression Screw (K230397)GM Dos Reis Industria e Comercio Ltda.2023-06-12
Acumed Acutrak 3 Headless Compression Screw System (K230744)Acumed, LLC2023-06-09
Hand Trauma Threaded Nail System (K230908)Skeletal Dynamics, Inc.2023-04-28
SimpliFix Hip System (K230053)Stabiliz Orthopaedics, Inc.2023-04-19
TriMed Threaded Intramedullary Nail System (K230749)TriMed, Inc.2023-04-17
REVCON (TM) Screw System (K223392)Voom Medical Devices, Inc.2023-02-28
PROstep(TM) MIS 5mm Chamfer Screw System (K221645)Wright Medical Technology2023-02-17
Bony Trauma Extremity System (BTES) Screw Range, NX Nail (K230118)Field Orthopaedics Pty, Ltd.2023-02-16
OIC Intramedullary Screw System (K223761)Orthopaedic Implant Company2023-02-13
CREED™ Cannulated Screws (K223847)Glw, Inc.2023-01-25
Metal Cannulated Screw (K221090)Double Medical Technology, Inc.2023-01-10
Haymaker® Screw System (K222799)Orthocircle Spine D.B.A. OC Medical Devices2023-01-10
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (K221333)Acumed, LLC2022-12-29
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (K221193)OSSIO , Ltd.2022-12-23
Phantom Metatarsal Shortening System (K223184)Paragon 28, Inc.2022-12-16
BRM TOOL Screws, BIOPLAN Subtalar Implant (K222820)Brm Extremities2022-12-16
REDEMPTION Beaming System (K221342)Vilex, LLC2022-12-13
Metal Bone Screw (K220921)Double Medical Technology, Inc.2022-12-12
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (K222967)Avanti Orthopaedics, Inc.2022-11-23
Treace Medical Concepts (TMC) Hammertoe Fixation System (K222564)Treace Medical Concepts, Inc.2022-11-15
Nextra CH Cannulated Hammertoe System (K221610)Nextremity Solutions, Inc.2022-11-04
CurvaFix IM System (K222505)Curvafix, Inc.2022-10-27
Tandry Compression Screw System (K220359)Microware Precision Co., Ltd.2022-09-20
Arthrex Compression FT Pins (K220839)Arthrex, Inc.2022-09-19
CAPTIVATE® Compression Screws (K222409)Globus Medical, Inc.2022-09-08
Cannulated Screws (K213614)Maxxion Medical, LLC2022-08-03
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System (K220319)Stryker GmbH2022-06-10
Hand Trauma Screw System (K220723)Skeletal Dynamics, Inc.2022-05-12
ExsoMed INnate NanoTM Lag Screw System (K220892)Exsomed Corp.2022-04-27
Cannulated Compression Device System (K210146)Orthopedic Designs North America, Inc.2022-04-13
Medline UNITE IM Fibula Implant (K220511)Medline Industries, LP2022-03-22
SIGNUS SACRONAIL® Transsacral Stabilization System (K212755)Signus Medizintechnik GmbH2022-03-10
MectaScrew Extension (K203335)Medacta International S.A.2022-02-03
MIS Precision Chevron Bunion System (K211628)Relja Innovations, LLC2022-01-31
JuniOrtho Plating System™ (K213572)Orthofix Srl2022-01-18
BRM TOOL Screws (K203773)Brm Extremities Srl2022-01-14
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199)Stryker GmbH2022-01-11
DynaFuse Fixation System (K203595)MedShape, Inc.2022-01-04
Quick-Start Screws (K212547)Innovate Orthopaedics Limited2021-12-30
R3ACT Stabilization System (K211770)Paragon 28, Inc.2021-12-25
InCore Subtalar System (K213301)Nextremity Solutions, Inc.2021-12-21
OSSIOfiber Compression Screw, 3.5mm (K213596)OSSIO , Ltd.2021-12-21
Nextra CH Cannulated Hammertoe System (K213530)Nextremity Solutions, Inc.2021-12-09
Next →

Track HWC automatically

Every clearance here is in the API, with alerts when new ones post.