510(k) · Cleared
ClearedPiezosurgery Medical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piezosurgery S.R.L. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Apr 8, 2009 as substantially equivalent to K043310 (Synthes (Usa), 2005) and 2 other predicates after a 152-day review. Its family tree reaches back 5 generations to 1986. 1 of the 29 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Apr 8, 2009
- Review
- 152 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K862807 (1986). 19 ancestors in all, the oldest K852143 (1985). 9 later devices descend from it, 2 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 4 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 2 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 1 generation backK990524 E9000 SystemLinvatec Corp. · 1999
- This deviceK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- Descendant · cites it directly · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · cites it directly · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · 2 generations on · 2 of its ownK172464 XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018
- Descendant · 2 generations on · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
- Descendant · 3 generations on · 0 of its ownK243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350…W&H Dentalwerk Buermoos GmbH · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K043310 Synthes (Usa) Electric Pen Drive Systemdirect predicate · 2005
Most influential descendants
Showing 5 of 9 · See all- K100410Piezoelectric SystemSatelec · 2010 · cites it directly8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · cites it directly6descendants
- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · 2 generations on2descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · 2 generations on2descendants
- K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −4 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −2 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −1 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| 0 (this device) | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| +1 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +1 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +2 | K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018 | — |
| +2 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| +3 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed… | W&H Dentalwerk Buermoos GmbH | 2025 | — |
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 |
| 2004 | 1 | 0 |
| 2005 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K043310 | Synthes (Usa) Electric Pen Drive SystemSummary page 2…311 Concept Boulevard Via Loreto, 15/A Paoli, PA 19301 USA Largo, FL 33773-4908 USA 16042 Carasco (GE) ITALY K043310 K990524 K043408 Device Description: The Piezosurgery® Medical device is… | 2005 |
| * | K990524 | E9000 SystemSummary page 2…eto, 15/A Paoli, PA 19301 USA Largo, FL 33773-4908 USA 16042 Carasco (GE) ITALY K043310 K990524 K043408 Device Description: The Piezosurgery® Medical device is an ultrasonic surgical system consisting o… | 1999 |
| * | K043408 | Piezosurgery DeviceSummary page 2…9301 USA Largo, FL 33773-4908 USA 16042 Carasco (GE) ITALY K043310 K990524 K043408 Device Description: The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two… | 2005 |
What descends from it? (9)
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 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K100410 (Satelec, 2010) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K043310.
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. 2009, 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 MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It 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/K083284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083284: Piezosurgery Medical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083284
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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