510(k) · Cleared
Recalled · Class I · 2016Synthes (Usa) Electric Pen Drive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Jan 5, 2005 after a 35-day review. The FDA summary names its predicate without a number. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled 6 times, including 2 Class I recalls.
- Decided
- Jan 5, 2005
- Review
- 35 days
- Class
- Class I
- Product code
- HWE
- Recalls
- 6 (2 Class I)
- Predicates
- 0
11 later devices descend from it, 3 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- This deviceK043310 Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 2005
- Descendant · cites it directly · 9 of its ownK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- Descendant · cites it directly · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · 2 generations on · 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 · 3 generations on · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K083284Piezosurgery MedicalPiezosurgery S.R.L. · 2009 · cites it directly9descendants
- K100410Piezoelectric SystemSatelec · 2010 · cites it directly8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · 2 generations on6descendants
- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · 2 generations on2descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043310 | Synthes (Usa) Electric Pen Drive System | Synthes (Usa) | 2005 | — |
| +1 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| +1 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +2 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +2 | K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018 | — |
| +3 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Stryker Total Performance (TPS) System Named without a submission number |
What descends from it? (11)
See all 113 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2016 | Class II | Z-0681-2017 | Under Investigation by firm | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. |
| Jun 24, 2016 | Class I | Z-2784-2016 | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. |
| Jun 24, 2016 | Class I | Z-2783-2016 | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. |
| May 31, 2016 | Class II | Z-2199-2016 | Labeling False and Misleading | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard. |
| Dec 19, 2014 | Class II | Z-1313-2015 | Process design | In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged. |
| Apr 15, 2013 | Class II | Z-0615-2014 | Process design | Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083284 (Piezosurgery S.R.L., 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes Electric Pen Drive (EPD) System is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including but not limited to general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043310: Synthes (Usa) Electric Pen Drive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043310
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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