# K043310: Synthes (Usa) Electric Pen Drive System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 5, 2005 after 35 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Total Performance (TPS) System: named in the summary without a submission number

## Most influential descendants
- K083284: Piezosurgery Medical (2009), 9 descendants of its own
- K100410: Piezoelectric System (2010), 8 descendants of its own
- K132848: Piezosurgery Flex (2013), 6 descendants of its own
- K172464: XD880A Ultrasonic Osteotomy Surgical System (2018), 2 descendants of its own
- K153743: Piezosurgery Plus (2016), 2 descendants of its own

## Recalls of this device
- Nov 1, 2016 · Class II · Z-0681-2017: 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: 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: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K043310
Methodology: https://510kreport.com/methodology