OSTEOPOWER SYSTEM AND ACCESSORIES

K971692 · Osteomed Corp. · KMW · Jun 27, 1997 · Dental

Device Facts

• Record ID: K971692
• Device Name: OSTEOPOWER SYSTEM AND ACCESSORIES
• Applicant: Osteomed Corp.
• Product Code: KMW · Dental
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.

Device Story

OsteoPower System is a powered surgical instrument set used for drilling, cutting, and driving fixation hardware (screws, pins, wires) into bone or teeth. Operated by surgeons in clinical/OR settings during reconstructive procedures (dental, craniofacial, orthopedic). System provides mechanical power to surgical attachments to facilitate bone/tooth manipulation and hardware placement. Benefits include precise bone/tooth modification and efficient hardware installation during complex surgical reconstructions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered surgical system for bone/tooth manipulation. Includes handpiece and various surgical accessories/attachments for drilling, cutting, and driving hardware. Mechanical energy source. Sterilization required for surgical use.

Indications for Use

Indicated for patients requiring bone or tooth drilling, cutting, or the insertion of screws, pins, and wires during dental, craniofacial, craniotomy, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgeries.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cindy Walters Quality Assurance Manager Osteomed Corporation 3150 Premier Drive #110 Irvinq, Texas 75063

JUN 27 1997

K971692 Re : OsteoPower System and Accessories Trade Name: Requlatory Class: II Product Code: KMW Dated: May 06, 1997 Received: May 07, 1997

Dear Ms. Walters:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Walters

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director

Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: OsteoPower System and Accessories

Indications for Use:

Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluaton (ODE)

Sunder Kumar

(Division Sign-Off) Division of Dental, Infection Control, and General Hospity 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)