Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

FDA 510(k) K222967 · Avanti Orthopaedics, Inc.

Substantially Equivalent

510(k) numberK222967

Submission

Device name
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
Applicant
Avanti Orthopaedics, Inc.
Wilmington, DE, US
Received
September 27, 2022
Decision date
November 23, 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

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K261057ActivaScrew™ Cannulated COMHWC · Traditional Bioretec, Ltd.09/04/2026SE
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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.

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K261145Avanti Distal Elbow ORIF SystemHRS · Abbreviated 05/09/2026SE
K211592Avanti Orthopaedics Ulnar Shortening SystemHRS · Traditional 07/16/2021SE
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Questions and answers

When was Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws cleared by the FDA?

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (K222967) received a 510(k) decision of Substantially Equivalent on November 23, 2022, 57 days after the submission was received.

What is the product code of K222967?

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