Product Code: JDX FDA class 2 21 CFR 888.4580

Instrument, Surgical, Sonic And Accessory/Attachment

Orthopedic

The Sonic Surgical Instrument and Accessory is an orthopedic surgical tool that uses ultrasonic energy to cut, shape, or ablate bone and tissue during procedures such as joint reconstruction or fracture management. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification prior to marketing. The product code is JDX, regulated under 21 CFR 888.4580, within the Orthopedic medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JDX
Device Class: FDA class 2
Regulation Number: 888.4580
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201274	Ultrasonic Osteotomy Surgical System	Feb 19, 2021	Substantially Equivalent	Smtp Technology Co., Ltd.
K172464	XD880A Ultrasonic Osteotomy Surgical System	Apr 24, 2018	Substantially Equivalent	Morley Research Consortium
K163610	PIEZOTOME M+, PIEZOTOME M+ Handpiece	May 19, 2017	Substantially Equivalent	Satalec-Acteon Group
K153743	PIEZOSURGERY PLUS	May 25, 2016	Substantially Equivalent	Mectron S.P.A.
K132848	PIEZOSURGERY FLEX	Nov 29, 2013	Substantially Equivalent	Mectron S.P.A.
K100410	PIEZOELECTRIC SYSTEM	Apr 28, 2010	Substantially Equivalent	Satelec
K093805	OSCAR 3	Feb 19, 2010	Substantially Equivalent	Orthosonics, Ltd.
K083284	PIEZOSURGERY MEDICAL	Apr 08, 2009	Substantially Equivalent	Piezosurgery S.R.L.
K083830	OSCAR BONE RESECTOR	Mar 20, 2009	Substantially Equivalent	Orthosonics, Ltd.
K072961	LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)	Dec 19, 2007	Substantially Equivalent	Sra Developments, Ltd.
K051053	OSCAR, MODEL OE3000DB	Jul 21, 2005	Substantially Equivalent	Orthosonics, Ltd.
K031280	ULTRA-DRIVE 3	Sep 22, 2003	Substantially Equivalent	Biomet, Inc.
K022729	VENTED CEMENT RESTRICTOR	Nov 14, 2002	Substantially Equivalent	Amedica Corp.
K002484	EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL	Oct 04, 2000	Substantially Equivalent	Electro Medical Systems SA
K961725	OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION	Aug 01, 1996	Substantially Equivalent	C.L. Mcintosh & Assoc., Inc.
K930109	KOMET MEDICAL SURGICAL POWER ACCESORIES	Aug 25, 1993	Substantially Equivalent	Brassler USA
K912931	ITM SONIC SURGERY SYSTEM	Oct 03, 1991	Substantially Equivalent	Buckman Co., Inc.
K911548	ACRYL-X SYSTEM TM	Jun 28, 1991	Substantially Equivalent	Sonokinetics, Inc.
K905451	SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE	Mar 05, 1991	Substantially Equivalent	Advanced Osseous Technologies
K900003	SYSTEM TEN MODEL 100 SURGICAL SYSTEM	Mar 16, 1990	Substantially Equivalent	Advanced Osseous Technologies
K891408	MODIFIED PROFILE HIP ACETABULAR PROSTHESIS	Jun 12, 1989	Substantially Equivalent	Depuy, Inc.
K862504	ACE MOS SAW AND THE ACE MOS SPINE SAW	Aug 07, 1986	Substantially Equivalent	Buckman Co., Inc.
K800501	PFIZER/AS&E 0450 LOCALIZER	Apr 10, 1980	Substantially Equivalent	Pfizer Medical Systems, Inc.