510(k) · Cleared
ClearedPiezoelectric System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Apr 28, 2010 as substantially equivalent to K083284 (Piezosurgery S.R.L., 2009) and 2 other predicates after a 71-day review. Its family tree reaches back 6 generations to 1986. 1 of the 33 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Apr 28, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K862807 (1986). 24 ancestors in all, the oldest K852143 (1985). 8 later devices descend from it, 3 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 4 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 2 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 1 generation backK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- This deviceK100410 Piezoelectric SystemSatelec · 2010
- Descendant · cites it directly · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK201274 Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd. · 2021
Showing 5 of 8 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 8 · See all- K132848Piezosurgery FlexMectron S.P.A. · 2013 · cites it directly6descendants
- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · cites it directly2descendants
- 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
- K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −5 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −4 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −2 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −1 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| 0 (this device) | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +1 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +1 | 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 | — |
| +2 | K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | 2021 | — |
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 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K083284 | Piezosurgery MedicalSummary page 2…_ _ _ _ _ _ _ _ _ S nsor McrnSaSynthes SATELEC - ACTEON Knumber K083284 K043310 K091252 D. Device Description The Satelec PIEZOELECTRIC SYSTEM… | 2009 |
| * | K043310 | Synthes (Usa) Electric Pen Drive SystemSummary page 2…_ S nsor McrnSaSynthes SATELEC - ACTEON Knumber K083284 K043310 K091252 D. Device Description The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consist… | 2005 |
| * | K091252 | Implant Center 2Summary page 2…McrnSaSynthes SATELEC - ACTEON Knumber K083284 K043310 K091252 D. Device Description The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consists of a console, a power cord… | 2009 |
What descends from it? (8)
3 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 24 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K132848 (Mectron S.P.A., 2013) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K083284.
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. 2010, 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 Piezoelectric System, distributed by Synthes, is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotom~y, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100410: Piezoelectric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100410
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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