SIGN Hip Construct (SHC)

Q: What is the product code of K152757?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.

FDA 510(k) K152757 · Sign Fracture Care International

Substantially Equivalent

510(k) numberK152757

Submission

Device name: SIGN Hip Construct (SHC)
Applicant: Sign Fracture Care International
Richland, WA, US
Received: September 24, 2015
Decision date: November 13, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HSB – Rod, Fixation, Intramedullary And Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3020
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HSB

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K253080	AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional	Suzhou and Science & Technology Development Corp.	06/18/2026SE
K253155	Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional	Beijing Fule Science & Technology Development…	06/17/2026SE
K253046	HERA Interlocking Intramedullary Nailing SystemHSB · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	06/16/2026SE
K260146	Fitbone® Transport and Lengthening SystemHSB · Traditional	Orthofix Srl	05/19/2026SE
K253991	Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional	Orthofix Srl	05/08/2026SE
K261043	AUTOBAHN Nailing SystemHSB · Special	Globus Medical, Inc.	04/24/2026SE
K252016	Arthrex Humeral NailsHSB · Traditional	Arthrex, Inc.	03/20/2026SE
K252961	Fusion FibFix NailHSB · Traditional	Fusion Orthopedics USA, LLC	03/18/2026SE

More from Fusion Orthopedics USA, LLC

510(k)	Device	Decision
K163589	SIGN IM NailHSB · Traditional	07/20/2017SE
K153759	SIGN Compression Screw SystemHWC · Traditional	02/25/2016SE
K122823	Sign Pediatric Fin NailHSB · Traditional	04/16/2013SE

Questions and answers

When was SIGN Hip Construct (SHC) cleared by the FDA?

SIGN Hip Construct (SHC) (K152757) received a 510(k) decision of Substantially Equivalent on November 13, 2015, 50 days after the submission was received.

What is the product code of K152757?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.