Odi Ultimate Compression Hip Screw

FDA 510(k) K984331 · Orthopedic Designs, Inc.

Substantially Equivalent

510(k) numberK984331

Submission

Device name
Odi Ultimate Compression Hip Screw
Applicant
Orthopedic Designs, Inc.
St. Petersburg, FL, US
Received
December 3, 1998
Decision date
January 20, 1999
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

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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
K030619Odi 7.0MM Cannulated Screw SystemHTN · Traditional 04/01/2003SE
K014189Odi Talon Intramedullary Hip NailJDS · Traditional 03/21/2002SE
K972722Ultimate Compression Screw SystemHWC · Traditional 01/23/1998SN

Questions and answers

When was Odi Ultimate Compression Hip Screw cleared by the FDA?

Odi Ultimate Compression Hip Screw (K984331) received a 510(k) decision of Substantially Equivalent on January 20, 1999, 48 days after the submission was received.

What is the product code of K984331?

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