Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4580](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4580) → JDX — Instrument, Surgical, Sonic And Accessory/Attachment # JDX · Instrument, Surgical, Sonic And Accessory/Attachment _Orthopedic · 21 CFR 888.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX ## Overview - **Product Code:** JDX - **Device Name:** Instrument, Surgical, Sonic And Accessory/Attachment - **Regulation:** [21 CFR 888.4580](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4580) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) ## 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. ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K201274](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K201274.md) | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | Feb 19, 2021 | SESE | | [K172464](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K172464.md) | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | Apr 24, 2018 | SESE | | [K163610](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K163610.md) | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | May 19, 2017 | SESE | | [K153743](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K153743.md) | PIEZOSURGERY PLUS | Mectron S.P.A. | May 25, 2016 | SESE | | [K132848](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K132848.md) | PIEZOSURGERY FLEX | Mectron S.P.A. | Nov 29, 2013 | SESE | | [K100410](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K100410.md) | PIEZOELECTRIC SYSTEM | Satelec | Apr 28, 2010 | SESE | | [K093805](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K093805.md) | OSCAR 3 | Orthosonics, Ltd. | Feb 19, 2010 | SESE | | [K083284](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K083284.md) | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | Apr 8, 2009 | SESE | | [K083830](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K083830.md) | OSCAR BONE RESECTOR | Orthosonics, Ltd. | Mar 20, 2009 | SESE | | [K072961](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K072961.md) | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Sra Developments, Ltd. | Dec 19, 2007 | SESE | | [K051053](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K051053.md) | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | Jul 21, 2005 | SESE | | [K031280](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K031280.md) | ULTRA-DRIVE 3 | Biomet, Inc. | Sep 22, 2003 | SESE | | [K022729](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K022729.md) | VENTED CEMENT RESTRICTOR | Amedica Corp. | Nov 14, 2002 | SESE | | [K002484](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K002484.md) | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | Oct 4, 2000 | SESE | | [K961725](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K961725.md) | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | Aug 1, 1996 | SESE | | [K930109](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K930109.md) | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | Aug 25, 1993 | SESE | | [K912931](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K912931.md) | ITM SONIC SURGERY SYSTEM | Buckman Co., Inc. | Oct 3, 1991 | SESE | | [K911548](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K911548.md) | ACRYL-X SYSTEM TM | Sonokinetics, Inc. | Jun 28, 1991 | SESE | | [K905451](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K905451.md) | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Advanced Osseous Technologies | Mar 5, 1991 | SESE | | [K900003](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K900003.md) | SYSTEM TEN MODEL 100 SURGICAL SYSTEM | Advanced Osseous Technologies | Mar 16, 1990 | SESE | ## Top Applicants - Orthosonics, Ltd. — 3 clearances - Advanced Osseous Technologies — 2 clearances - Buckman Co., Inc. — 2 clearances - Mectron S.P.A. — 2 clearances - Amedica Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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