SIGN Compression Screw System

FDA 510(k) K153759 · Sign Fracture Care International

Substantially Equivalent

510(k) numberK153759

Submission

Device name
SIGN Compression Screw System
Applicant
Sign Fracture Care International
Richland, WA, US
Received
December 30, 2015
Decision date
February 25, 2016
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
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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.

510(k)DeviceDecision
K163589SIGN IM NailHSB · Traditional 07/20/2017SE
K152757SIGN Hip Construct (SHC)HSB · Traditional 11/13/2015SE
K122823Sign Pediatric Fin NailHSB · Traditional 04/16/2013SE

Questions and answers

When was SIGN Compression Screw System cleared by the FDA?

SIGN Compression Screw System (K153759) received a 510(k) decision of Substantially Equivalent on February 25, 2016, 57 days after the submission was received.

What is the product code of K153759?

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