# K961970: Command 2 Micoelectric Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jul 26, 1996 after 67 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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) Powered instruments, controls, and associated accessories marketed by Stryker prior to the 1976 Medical Devices Amendment: named in the summary without a submission number
- (no number) Power sources distributed by MicroAire: named in the summary without a submission number

## Recalls of this device
- Jun 2, 2010 · Not classified · Z-2420-2010: The reason for the field action is that the inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tap
- Jan 27, 2009 · Not classified · Z-1052-2009: Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.

## Indications for 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.

Source page: https://510kreport.com/device/K961970
Methodology: https://510kreport.com/methodology