SYNTHES 90 DEGREE SCREWDRIVER

K082649 · Synthes (Usa) · DZI · Apr 30, 2009 · Dental

Device Facts

• Record ID: K082649
• Device Name: SYNTHES 90 DEGREE SCREWDRIVER
• Applicant: Synthes (Usa)
• Product Code: DZI · Dental
• Decision Date: Apr 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.

Device Story

Synthes 90° Screwdriver is a surgical instrument system comprising a handle, shaft, screw holder, and screw holder insert. It accepts various attachments, including drill bits and screwdriver blades. The device is used in oral/maxillofacial surgery for pre-drilling and inserting bone fixation screws. It supports both manual and powered operation. By providing a right-angled access point, it facilitates screw placement in constrained surgical sites, assisting surgeons in bone fixation procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical surgical instrument; right-angled configuration; includes handle, shaft, screw holder, and attachments (drill bits, screwdriver blades). Supports manual and powered operation. No software or electronic components.

Indications for Use

Indicated for manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery patients.

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

• Synthes Electric Pen Drive System

Submission Summary (Full Text)

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510(k) Summary

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| Sponsor: | Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 Contact: Andrea M. Tasker Phone: [phone] Fax: [phone] [e-mail] |
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| Device Name: | Synthes 90 ° Screwdriver |
| Classification: | Regulation Number: §872.4120 Device: drill, bone, powered Regulation Description: Bone cutting instrument and accessories Regulation Medical Specialty: Dental . |
| Predicate Device: | Synthes Electric Pen Drive System |
| Device Description: | The Synthes 90 ° Screwdriver consists of a screwdriver handle, shaft, screw holder, screw holder insert and a variety of attachments such as drill bits and screwdriver blades for manual and powered right angled pre-drilling and insertion of screws. |
| Intended Use: | The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery. |
| Substantial Equivalence: | Documentation provided supports substantial equivalence to other legally marketed devices such as the Synthes Electric Pen Drive System. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Andrea M. Tasker CMF Regulatory Affairs Manager Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

## APR 3 0 2009

Re: K082649

Trade/Device Name: Synthes 90 ° Screwdriver Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, DZJ Dated: April 17, 2009 Received: April 29, 2009

Dear Ms. Tasker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration

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Page 2- Ms. Tasker

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Christer V.m.ton

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.0 Indications for Use

510(k) Number (if known):

K082649

Device Name:

Synthes 90 ° Screwdriver

Indications for Use:

The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.

X Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muluy for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

.510(k) Number: K082649