Cannulated Compression Device System

FDA 510(k) K210146 · Orthopedic Designs North America, Inc.

Substantially Equivalent

510(k) numberK210146

Submission

Device name
Cannulated Compression Device System
Applicant
Orthopedic Designs North America, Inc.
Tampa, FL, US
Received
January 21, 2021
Decision date
April 13, 2022
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
K173255Talon DistalFix Humeral NailHSB · Traditional 02/22/2018SE
K152295Talon DistalFix Antegrade/Retrograde Femoral NailHSB · Traditional 11/03/2015SE
K111352Talon Distalfix Proximal Femoral NailHSB · Abbreviated 08/22/2011SE

Questions and answers

When was Cannulated Compression Device System cleared by the FDA?

Cannulated Compression Device System (K210146) received a 510(k) decision of Substantially Equivalent on April 13, 2022, 447 days after the submission was received.

What is the product code of K210146?

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