Arc Surgical Resorbable Compression Screw System

FDA 510(k) K043176 · Arc Surgical, LLC

Substantially Equivalent

510(k) numberK043176

Submission

Device name
Arc Surgical Resorbable Compression Screw System
Applicant
Arc Surgical, LLC
Hillsboro, OR, US
Received
November 16, 2004
Decision date
June 17, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HWC

510(k)DeviceApplicantDecision
K261057ActivaScrew™ Cannulated COMHWC · Traditional Bioretec, Ltd.09/04/2026SE
K260106OsteoCoil™ GT Active Compression SystemHWC · Traditional Flower Orthopedics Corporation DBA Conventus…08/24/2026SE
K262344Large Compression ScrewsHWC · Special TriMed, Inc.08/12/2026SE
K253858GFS - Sterile Screws and Top HatHWC · Special T.A.G. Medical Products Corporation, Ltd.08/05/2026SE
K262075Lapidus Screw KitHWC · Special Relja Innovations, LLC07/22/2026SE
K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemHWC · Traditional Arthrex, Inc.06/25/2026SE
K253108VEOFIX Snap Off ScrewHWC · Traditional Steps Ortho06/05/2026SE
K261154CoLink® & CoLag® Non-Sterile ScrewsHWC · Special In2Bones USA, LLC05/30/2026SE
K261241TriMed Compression ScrewsHWC · Special TriMed, Inc.05/14/2026SE
K254215Arthrex Beaming SystemHWC · Traditional Arthrex, Inc.05/08/2026SE

More from Arthrex, Inc.

510(k)DeviceDecision
K141559V-Guide for VentriculostomiesHAW · Traditional 02/27/2015SE
K071616Arc Surgical Biotrak Pin SystemHTY · Traditional 12/19/2007SE
K063244Arc Surgical Bone Reduction ScrewHWC · Traditional 12/27/2006SE
K061763Arc Surgical Biotrak ScrewHWC · Traditional 09/19/2006SE

Questions and answers

When was Arc Surgical Resorbable Compression Screw System cleared by the FDA?

Arc Surgical Resorbable Compression Screw System (K043176) received a 510(k) decision of Substantially Equivalent on June 17, 2005, 213 days after the submission was received.

What is the product code of K043176?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.