SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM— 510(k) K043310

Clearance details

Applicant

Synthes (Usa)

Product code

Code HWE

Device class

Class 1

Regulation

21 CFR 878.4820

Advisory panel

General, Plastic Surgery

Date received

2004-12-01

Decision date

2005-01-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Paoli, PA, US

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• K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE2007-01-16
• K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM2005-05-26
• K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS2002-09-18

• K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM2015-03-30
• K131984 — SYNTHES SYNSONIC ULNA NAIL2014-03-31
• K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE2012-07-06
• K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM2012-06-18
• K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)2012-05-08

Death

4

Injury

448

Malfunction

19,856

Other

2

Total

20,310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0681-2017 — Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-SterileClass II·Terminated·Synthes (USA) Products LLC·20161101
• Z-2783-2016 — Light Adaptor for Small Battery Drive and Small Battery Drive II.Class I·Terminated·The Anspach Effort, Inc.·20160624
• Z-2784-2016 — Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.Class I·Terminated·The Anspach Effort, Inc.·20160624
• Z-2199-2016 — Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.Class II·Terminated·Synthes (USA) Products LLC·20160531
• Z-1313-2015 — Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.Class II·Terminated·Synthes, Inc.·20141219
• Z-0615-2014 — Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.Class II·Terminated·Synthes USA HQ, Inc.·20130415

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043310.