THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K972463 · Biomedics · JEY · Sep 25, 1997 · Dental

Device Facts

• Record ID: K972463
• Device Name: THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
• Applicant: Biomedics
• Product Code: JEY · Dental
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and non-load bearing fixation, reconstructive procedures of the skeleton, orbital rim fixation, maxillary fixation, graft fixation, bone fixation, brow fixation. The device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Device Story

Bioplate Rigid Fixation Bone Plating System consists of titanium plates and screws for craniomaxillofacial surgery. Device provides mechanical stabilization of bone segments during healing or reconstruction. Used by surgeons in clinical/OR settings. System components are implanted to provide rigid fixation; intended for single use. Benefits include structural support for bone fractures and reconstructive sites. System is designed for use with other titanium/titanium alloy implants.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and construction comparison to predicate devices.

Technological Characteristics

Materials: Commercially pure titanium and titanium 6Al-4V ELI alloy. Form factor: Bone plates and screws for rigid fixation. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for patients requiring fracture treatment, non-load bearing fixation, or reconstructive skeletal procedures in the craniomaxillofacial region, including orbital rim, maxillary, graft, bone, and brow fixation.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Biomedics, Inc. (not specified)
• W.L. Lorenz (not specified)
• Synthes (USA) (not specified)

Submission Summary (Full Text)

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## SEP 2 5 1997

17 1163

## BIOMEDICS, INC. 536 South Rimpau Boulevard Los Angeles, California 90020-4832 Tel: [phone], FAX: [phone]

## Summary of Safety and Effectiveness

This statement regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.)

The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

SEP 2 5 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol E. Jones Biomedics, Incorporated 536 South Rimpau Boulevard Los Angeles, California 90020

Re : K972463 The Bioplate Rigid Fixation Bone Plating Trade Name: System for Craniomaxillofacial Surgery II Requlatory Class: Product Code: JEY July 1, 1997 Dated: Received: July 1, 1997

Dear Ms. Jones:

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, Druq, 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Jones

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timõ thy A. Ulatowski 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 (if known):

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating Device Name: System for Craniomaxillofacial Surgery

Indications For Use:

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plaing rne place and Sorow dooging for use intended for use in the treatment of fractures and System for Orahomaxillolation ourgery is keleton and non-load bearing fixation, stration, stration, stration, stration, start fixstion, start fixstien, start fixstien reconstructive proovative of the nation, orbital rim fixation , maxillary fixation, graft fixation bone lixation, brow likation, Eygendate is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Susan Gunnes<br>(Division Sign-Off)<br>Division of Dental, Infection Control,<br>and General Hospital Devices |
| 510(k) Number | Ka 72463 |
| Prescription Use | <div style="display:inline-block;">✓</div> (Per 21 CFR 801.109) OR Over-The-Counter Use _______ (Optional Format 1-2-96) |