STRYKER ORAL MAX SYSTEM

K954690 · Stryker Corp. · DZI · Aug 20, 1996 · Dental

Device Facts

• Record ID: K954690
• Device Name: STRYKER ORAL MAX SYSTEM
• Applicant: Stryker Corp.
• Product Code: DZI · Dental
• Decision Date: Aug 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oral Max 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 but not limited to, dental and oral surgery. It is also usable in the placement of screws.

Device Story

Electrically powered surgical system; includes console, handpieces, and accessories. Used for cutting, drilling, reaming, decorticating, smoothing bone/tissue, and screw placement. Operated by surgeons in clinical/surgical settings. System provides mechanical power to attachments for precise bone contact. Benefits include controlled surgical site access and tissue modification. Safety managed via operator manual, duty cycles, and adherence to electrical standards.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design comparison, material analysis, and adherence to electrical safety standards (CSA 22.2, UL 544).

Technological Characteristics

Electrically powered surgical system. Components: console, handpieces, accessories. Materials and cutting surface configurations equivalent to pre-1976 predicate devices. Standards: CSA 22.2, UL 544. Cutting accessories provided sterile.

Indications for Use

Indicated for patients requiring bone surgery, including dental and oral procedures, involving cutting, drilling, reaming, decorticating, smoothing of bone/tissue, and screw placement.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Powered instruments, controls, and associated accessories marketed by Stryker prior to 1976
• Power sources distributed by Aeseptico

Submission Summary (Full Text)

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AUG 20 1996
K954690 stryker
INSTRUMENTS
4100 East Milham Avenue
Kalamazoo, MI 49001-6197
[phone] [phone]

## Device Name:

**Classification Names:** Drill, Bone, Powered; 21 CFR 872.4120, Class II
Bur, Dental; 21CFR 872.3240, Class I
Controller, Foot, Handpiece and Cord; 21 CFR 872.4200, Class I

**Common/Usual Name:** Electrical Powered Surgical Instruments and Accessories/Attachments

**Proprietary Name:** Stryker Oral Max 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 Oral Max 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 but not limited to, dental and oral surgery. It is also usable in the placement of screws.

The Stryker Oral Max 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 Oral Max 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.

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The power source/console described in this submission is equivalent to power sources distributed by Aeseptico. Intended use, function, and safety risks are all substantially equivalent. Safety warnings and operating duty cycles are listed in the Oral Max Operator's Manual. In addition, the Stryker Oral Max System is designed to meet the following Standards: CSA 22.2; UL 544.

The Stryker Oral Max System does not raise any new safety and efficacy concerns when compared to similar devices already being marketed. Therefore, the Stryker Oral Max System is substantially equivalent to these existing devices.


Tammy Lounds
Supervisor, Regulatory Affairs
Stryker Instruments