510(k) · Cleared
ClearedPiezosurgery Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mectron S.P.A. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on May 25, 2016 as substantially equivalent to K132848 (Mectron S.P.A., 2013) and 1 other predicate after a 149-day review. Its family tree reaches back 8 generations to 1986. 1 of the 33 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 25, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K862807 (1986). 30 ancestors in all, the oldest K801623 (1980). 2 later devices descend from it, 2 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 4 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 3 generations backK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- 2 generations backK100410 Piezoelectric SystemSatelec · 2010
- 1 generation backK132848 Piezosurgery FlexMectron S.P.A. · 2013
- This deviceK153743 Piezosurgery PlusMectron S.P.A. · 2016
- Descendant · cites it directly · 0 of its ownK243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350…W&H Dentalwerk Buermoos GmbH · 2025
- Descendant · cites it directly · 0 of its ownK192033 Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip…Bennett Jacoby, Dds, Ms, Inc. · 2020
Class I recalls in this family
- K043310 Synthes (Usa) Electric Pen Drive System3 generations back · 2005
Most influential descendants
Showing 2 of 2 · See all- K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH · 2025 · cites it directly0descendants
- K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −7 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −4 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −3 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| −2 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| −1 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| 0 (this device) | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| +1 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed… | W&H Dentalwerk Buermoos GmbH | 2025 | — |
| +1 | K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour… | Bennett Jacoby, Dds, Ms, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 1 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K132848 | Piezosurgery FlexSummary page 5…turer Product Code 510(k) Number Decision Date Piezosurgery Flex MECTRON Spa JDX, DZI, ERL, HBE, HWE K132848 29 November 2013 Alliger Ultrasonic Surgical MISONIX INC LFL… | 2013 |
| * | K070313 | Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemSummary page 5…E, HWE K132848 29 November 2013 Alliger Ultrasonic Surgical MISONIX INC LFL K070313 11 May 2007 System Model AUSS-7 4. DEVICE DESCRIPTION AND TECHNOLOGICAL CHARACTERISTICS The Piezosurgery Plus… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243280 (W&H Dentalwerk Buermoos GmbH, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132848.
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. 2016, 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?
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- Otolaryngology
- Oral/maxillofacial
- Hand and foot
- Neurosurgery
- Spine
- Plastic/reconstructive, and
- Orthopedic surgery.
The device may also be used with endoscopic visual assistance to perform the above listed procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153743: Piezosurgery Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153743
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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