HWC · Screw, Fixation, Bone

Orthopedic · 21 CFR 888.3040 · Class 2

Overview

Product CodeHWC
Device NameScrew, Fixation, Bone
Regulation21 CFR 888.3040
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Recent Cleared Devices (20 of 1054)

Showing 20 most recent of 1054 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K260934TITAN Nail; APTUS K-Wire SystemMedartis AGApr 17, 2026SESE
K252699CoAptix S SystemUniversity of Utah, Department of OrthopaedicsApr 10, 2026SESE
K253042Tyber Medical Trauma ScrewTyber Medical, LLCApr 3, 2026SESE
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.Mar 18, 2026SESE
K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.Mar 6, 2026SESE
K252901Tyber Medical Trauma ScrewTyber Medical, LLCDec 31, 2025SESE
K251555Ultra™ Compression Screw SystemPace SurgicalNov 6, 2025SESE
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev4Oct 10, 2025SESE
K250536MetaFore Small Screw SystemExtremity Medical, LLCOct 8, 2025SESE
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.Oct 2, 2025SESE
K252019CurvaFix Low Profile SystemCurvafix, Inc.Aug 29, 2025SESE
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.Aug 27, 2025SESE
K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLCAug 15, 2025SESE
K250251Eleganz Fusion Screw System (Fusion Screw System)Dev4Jun 13, 2025SESE
K243943TriMed® Compression ScrewsTriMed, Inc.Apr 10, 2025SESE
K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.Apr 2, 2025SESE
K250304TITANEX Screw SystemsVilex, LLCMar 5, 2025SESE
K242896Caliber Intramedullary Fixation SystemNvision Biomedical TechnologiesFeb 5, 2025SESE
K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics, Ltd.Jan 31, 2025SESE
K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.Jan 10, 2025SESE

Top Applicants

Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...