510(k) · Cleared
ClearedPIEZOTOME M+, PIEZOTOME M+ Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satalec-Acteon Group · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on May 19, 2017 as substantially equivalent to K100410 (Satelec, 2010) and 1 other predicate after a 148-day review. Its family tree reaches back 7 generations to 1986. 1 of the 28 devices in its family, counting itself, has a Class I recall.
- Decided
- May 19, 2017
- Review
- 148 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K862807 (1986). 27 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 6 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 4 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 3 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 2 generations backK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- 1 generation backK100410 Piezoelectric SystemSatelec · 2010
- This deviceK163610 PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group · 2017
Class I recalls in this family
- K043310 Synthes (Usa) Electric Pen Drive System2 generations back · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −6 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −4 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −3 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −2 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| −1 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| 0 (this device) | K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 1 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDX device
- #1 K201274 Ultrasonic Osteotomy Surgical Systemscore 3.3 · 9 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100410 | Piezoelectric SystemSummary page 5…510(k) number Date Cleared JDX, DZI, ERL, Piezoelectric System SATELEC K100410 April 28, 2010 HBE, HWE PIEZOTOME 2 SATELEC… | 2010 |
| * | K091331 | Piezotome 2Summary page 5…K100410 April 28, 2010 HBE, HWE PIEZOTOME 2 SATELEC DZI K091331 Dec 11, 2009 SATELEC Piezoelectric System Predicate Device has not been subject to a design-related recall. SATELEC… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K043310Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K100410.
How does its category compare?
All JDX devicesJDX Instrument, Surgical, Sonic And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JDX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDX
Too few JDX 510(k)s in any year since 2007 to give a median.
Recalls per year · JDX
No recall names JDX since 2007.
Adverse event reports per year · JDX
9in 2025
MAUDE reports naming product code JDX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 8 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.
Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163610: PIEZOTOME M+, PIEZOTOME M+ Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163610
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026