Instrument, Surgical, Sonic And Accessory/Attachment
FDA product code JDX · Class II (moderate risk) · 21 CFR 888.4580 · Orthopedic
23510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Orthosonics, Ltd. 3
- Buckman Co., Inc. 2
- Advanced Osseous Technologies 2
- Mectron S.P.A. 2
- Smtp Technology Co., Ltd. 1
- Pfizer Medical Systems, Inc. 1
- Morley Research Consortium 1
- Satalec-Acteon Group 1
- Satelec 1
- Piezosurgery S.R.L. 1
- Sra Developments, Ltd. 1
- Biomet, Inc. 1
- Amedica Corp. 1
- Electro Medical Systems SA 1
- C.L. Mcintosh & Assoc., Inc. 1
- Brassler USA 1
- Sonokinetics, Inc. 1
- Depuy, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical SystemJDX · Traditional | Smtp Technology Co., Ltd. | 02/19/2021SE |
| K172464 | XD880A Ultrasonic Osteotomy Surgical SystemJDX · Traditional | Morley Research Consortium | 04/24/2018SE |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ HandpieceJDX · Traditional | Satalec-Acteon Group | 05/19/2017SE |
| K153743 | Piezosurgery PlusJDX · Traditional | Mectron S.P.A. | 05/25/2016SE |
| K132848 | Piezosurgery FlexJDX · Traditional | Mectron S.P.A. | 11/29/2013SE |
| K100410 | Piezoelectric SystemJDX · Traditional | Satelec | 04/28/2010SE |
| K093805 | Oscar 3JDX · Traditional | Orthosonics, Ltd. | 02/19/2010SE |
| K083284 | Piezosurgery MedicalJDX · Traditional | Piezosurgery S.R.L. | 04/08/2009SE |
| K083830 | Oscar Bone ResectorJDX · Traditional | Orthosonics, Ltd. | 03/20/2009SE |
| K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)JDX · Traditional | Sra Developments, Ltd. | 12/19/2007SE |
| K051053 | Oscar, Model OE3000DBJDX · Traditional | Orthosonics, Ltd. | 07/21/2005SE |
| K031280 | Ultra-Drive 3JDX · Traditional | Biomet, Inc. | 09/22/2003SE |
| K022729 | Vented Cement RestrictorJDX · Traditional | Amedica Corp. | 11/14/2002SE |
| K002484 | EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalJDX · Traditional | Electro Medical Systems SA | 10/04/2000SE |
| K961725 | Oscar Orthosonics System for Cemented Arthroplasty RevisionJDX · Traditional | C.L. Mcintosh & Assoc., Inc. | 08/01/1996SE |
| K930109 | Komet Medical Surgical Power AccesoriesJDX · Traditional | Brassler USA | 08/25/1993SE |
| K912931 | Itm Sonic Surgery SystemJDX · Traditional | Buckman Co., Inc. | 10/03/1991SE |
| K911548 | Acryl-X System TMJDX · Traditional | Sonokinetics, Inc. | 06/28/1991SE |
| K905451 | System Ten, Model 100 Surgery Syst/Orthopaedic UseJDX · Traditional | Advanced Osseous Technologies | 03/05/1991SE |
| K900003 | System Ten Model 100 Surgical SystemJDX · Traditional | Advanced Osseous Technologies | 03/16/1990SE |
| K891408 | Modified Profile Hip Acetabular ProsthesisJDX · Traditional | Depuy, Inc. | 06/12/1989SE |
| K862504 | Ace Mos Saw and the Ace Mos Spine SawJDX · Traditional | Buckman Co., Inc. | 08/07/1986SE |
| K800501 | Pfizer/As&E 0450 LocalizerJDX · Traditional | Pfizer Medical Systems, Inc. | 04/10/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1963-2019 Class II | Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item…The products do not have sufficient data to support the labeled shelf life of 10 years. | Zimmer Biomet, Inc. | 06/04/2019Terminated |
| Z-1962-2019 Class II | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with…The products do not have sufficient data to support the labeled shelf life of 10 years. | Zimmer Biomet, Inc. | 06/04/2019Terminated |