Who is the manufacturer of COMMAND 2 MICOELECTRIC SURGICAL SYSTEM?

Stryker Corp. submitted the Traditional clearance for COMMAND 2 MICOELECTRIC SURGICAL SYSTEM (K961970).

What is the FDA product code for COMMAND 2 MICOELECTRIC SURGICAL SYSTEM?

HWE. It is classified under 21 CFR 878.4820 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for COMMAND 2 MICOELECTRIC SURGICAL SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for COMMAND 2 MICOELECTRIC SURGICAL SYSTEM?

Stryker powered instruments (pre-1976); MicroAire power sources.

COMMAND 2 MICOELECTRIC SURGICAL SYSTEM

K961970 · Stryker Corp. · HWE · Jul 26, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961970
Device Name	COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
Applicant	Stryker Corp.
Product Code	HWE · General, Plastic Surgery
Decision Date	Jul 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4820
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The Command2 MicroElectric System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including: ENT, dental, orthopedic, maxiofacial, spinal, and plastics. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices.

Device Story

System consists of electrically powered surgical instruments, control console, and power source; used for cutting, drilling, reaming, decorticating, and smoothing bone/tissue; facilitates placement/cutting of fixation hardware (screws, wires, pins). Operated by surgeons in clinical/OR settings. Provides mechanical power to surgical attachments; enables precise control over surgical contact location and extent. Benefits include surgical precision in diverse specialties.

Clinical Evidence

Bench testing only; no clinical data presented. Equivalence established through design comparison, material consistency, and adherence to recognized safety standards (CSA 22.2 No. 601.1-M90, UL 2601-1, IEC 601-1 series).

Technological Characteristics

Electrically powered surgical system; includes console, handpieces, and accessories. Materials equivalent to pre-1976 predicate devices. Standards: CSA 22.2 No. 601.1-M90, UL 2601-1, IEC 601-1, IEC 601-1-2, CISPR 11, IEC 1000-4-2/3/4/5. Sterilization provided for cutting accessories.

Indications for Use

Indicated for patients requiring bone or bone-related tissue surgery, including ENT, dental, orthopedic, maxillofacial, spinal, and plastic procedures, or placement/cutting of fixation devices like screws, wires, and pins.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

Stryker powered instruments (pre-1976)
MicroAire power sources

Related Devices

K954690 — STRYKER ORAL MAX SYSTEM · Stryker Corp. · Aug 20, 1996
K960853 — ACE SYSTEM · Xomed, Inc. · Apr 3, 1996
K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools · Medtronic Powered Surgical Solutions · May 15, 2017
K040369 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM · Stryker Instruments · Apr 1, 2004
K032303 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM · Stryker Instruments · Jan 16, 2004

Submission Summary (Full Text)

{0} K961970 stryker INSTRUMENTS 4100 East Milham Avenue Kalamazoo, MI 49001-6197 (616) 323-700 (800) 253-3210 JUL 26 1996 ## Device Name: Classification Names: Surgical Instrument Motors and Accessories/Attachments: 21 CFR 878.4820, Class I and Class II Common/Usual Name: Surgical instrument Motors and Accessories/Attachments Proprietary Name: Stryker Command2 MicroElectric Surgical System ## Device Sponsor: Stryker Corporation Instruments Division 4100 E. Milham Avenue Kalamazoo, MI 49001 Registration No: 1811755 Stryker Puerto Rico Las Palmas Industrial Park Highway 3, 130.2 Arroyo, Puerto Rico 00615 Registration No.: 2648666 ## Regulatory Classification: Class II ## Summary of Safety and Effectiveness: The Command2 MicroElectric System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including: ENT, dental, orthopedic, maxiofacial, spinal, and plastics. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. The Stryker Command2 MicroElectric System, consisting of electrically powered surgical instruments, controls, power source, and other system accessories, is equivalent in intended use, safety, and effectiveness to powered instruments, controls, and associated accessories that were marketed by Stryker prior to the 1976 Medical Devices Amendment. The cutting accessories available to be used with the Command2 MicroElectric System will be provided sterile. The materials of construction, cutting action, and cutting surface configuration are equivalent to devices distributed by Stryker prior to the 1976 Medical Devices Amendment. As proven in surgical procedures, these designs offer the required precision required for controlling the location and extent of the surgical contact. {1} The additional power source/console feature described in this submission is equivalent to existing power sources distributed by MicroAire. Intended use, function, and safety risks are all substantially equivalent. Safety warnings, malfunction troubleshooting, and operating duty cycles are listed in the Command2 MicroElectric System Operator's Manual. In addition, the Stryker Command2 MicroElectric System is designed to meet the following Standards: CSA 22.2 No. 601.1-M90, UL 2601-1 First Edition, IEC 601-1 with amendments, IEC 601-1-2, CISPR 11, IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4, IEC 1000-4-5. The Stryker Command2 MicroElectric System does not raise any new safety and efficacy concerns when compared to similar devices already being marketed. Therefore, the Stryker Command2 MicroElectric System is substantially equivalent to these existing devices. Diane Davis Regulatory Affairs Representative Stryker Instruments