510(k) · Cleared
ClearedPiezosurgery Flex
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 Nov 29, 2013 as substantially equivalent to K083284 (Piezosurgery S.R.L., 2009) and 1 other predicate after a 79-day review. Its family tree reaches back 7 generations to 1986. 1 of the 32 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Nov 29, 2013
- Review
- 79 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K862807 (1986). 25 ancestors in all, the oldest K852143 (1985). 6 later devices descend from it, 2 citing it directly. 1 of the 32 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 deviceK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · cites it directly · 2 of its ownK172464 XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018
- Descendant · cites it directly · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK192033 Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip…Bennett Jacoby, Dds, Ms, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K043310 Synthes (Usa) Electric Pen Drive System2 generations back · 2005
Most influential descendants
Showing 5 of 6 · See all- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · cites it directly2descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · cites it directly2descendants
- K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH · 2025 · 2 generations on0descendants
- K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc. · 2020 · 2 generations on0descendants
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) | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +1 | K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018 | — |
| +1 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| +2 | 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 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K083284 | Piezosurgery MedicalSummary page 1…PrdctCdesNumber Date Piezosurgery Medical MECTRON Spa JOX, OZI, ERL, HBE, HWE K083284 April 8, 2009 Piezoelectric System SATELEC-ACTEON Group JDX, OZI, ERI, HBE, HWE K100410 April 28, 2010… | 2009 |
| * | K100410 | Piezoelectric SystemSummary page 1…TRON Spa JOX, OZI, ERL, HBE, HWE K083284 April 8, 2009 Piezoelectric System SATELEC-ACTEON Group JDX, OZI, ERI, HBE, HWE K100410 April 28, 2010 Intended usellndications for Use: Piezosurgery FLEX is an ultrasonic surgical system consist… | 2010 |
What descends from it? (6)
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 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172464 (Morley Research Consortium, 2018) has gone furthest, with 2 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. 2013, 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 FLEX 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/K132848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132848: Piezosurgery Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132848
Report an extraction error
Are you the manufacturer?
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