JDX · Instrument, Surgical, Sonic And Accessory/Attachment
Orthopedic · 21 CFR 888.4580 · Class 2
Overview
| Product Code | JDX |
|---|---|
| Device Name | Instrument, Surgical, Sonic And Accessory/Attachment |
| Regulation | 21 CFR 888.4580 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
Cleared Devices (23)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | Feb 19, 2021 | SESE |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | Apr 24, 2018 | SESE |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | May 19, 2017 | SESE |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | May 25, 2016 | SESE |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | Nov 29, 2013 | SESE |
| K100410 | PIEZOELECTRIC SYSTEM | Satelec | Apr 28, 2010 | SESE |
| K093805 | OSCAR 3 | Orthosonics, Ltd. | Feb 19, 2010 | SESE |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | Apr 8, 2009 | SESE |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | Mar 20, 2009 | SESE |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | Dec 19, 2007 | SESE |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | Jul 21, 2005 | SESE |
| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | Sep 22, 2003 | SESE |
| K022729 | VENTED CEMENT RESTRICTOR | Amedica Corp. | Nov 14, 2002 | SESE |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | Oct 4, 2000 | SESE |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | Aug 1, 1996 | SESE |
| K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | Aug 25, 1993 | SESE |
| K912931 | ITM SONIC SURGERY SYSTEM | Buckman Co., Inc. | Oct 3, 1991 | SESE |
| K911548 | ACRYL-X SYSTEM TM | Sonokinetics, Inc. | Jun 28, 1991 | SESE |
| K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Advanced Osseous Technologies | Mar 5, 1991 | SESE |
| K900003 | SYSTEM TEN MODEL 100 SURGICAL SYSTEM | Advanced Osseous Technologies | Mar 16, 1990 | SESE |
| K891408 | MODIFIED PROFILE HIP ACETABULAR PROSTHESIS | Depuy, Inc. | Jun 12, 1989 | SESE |
| K862504 | ACE MOS SAW AND THE ACE MOS SPINE SAW | Buckman Co., Inc. | Aug 7, 1986 | SESE |
| K800501 | PFIZER/AS&E 0450 LOCALIZER | Pfizer Medical Systems, Inc. | Apr 10, 1980 | SESE |
Top Applicants
- Orthosonics, Ltd. — 3 clearances
- Mectron S.P.A. — 2 clearances
- Buckman Co., Inc. — 2 clearances
- Advanced Osseous Technologies — 2 clearances
- Sra Developments, Ltd. — 1 clearance
