Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

FDA 510(k) K231819 · Innovate Orthopaedics Limited

Substantially Equivalent

510(k) numberK231819

Submission

Device name
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Applicant
Innovate Orthopaedics Limited
Huddersfield, GB
Received
June 21, 2023
Decision date
September 5, 2023
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
K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewHWC · Traditional 01/31/2025SE
K212547Quick-Start ScrewsHWC · Traditional 12/30/2021SE

Questions and answers

When was Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw cleared by the FDA?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K231819) received a 510(k) decision of Substantially Equivalent on September 5, 2023, 76 days after the submission was received.

What is the product code of K231819?

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