OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM

K031701 · Osteomed LP · NEI · Jul 8, 2004 · Dental

Device Facts

• Record ID: K031701
• Device Name: OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
• Applicant: Osteomed LP
• Product Code: NEI · Dental
• Decision Date: Jul 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.

Device Story

Solid condylar head implant; attaches via fastening screws to OsteoMed Fracture Reconstruction Plate. Used for temporary mandibular condyle reconstruction following tumor resection. Available in left/right configurations. System includes manual drivers. Implanted by surgeons in clinical settings; intended for temporary use (max 1 year). Single patient use only.

Clinical Evidence

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

Technological Characteristics

Solid condylar head implant; metallic construction; attaches to mandibular reconstruction plates via screws. Manual instrumentation (drivers) included. Single-use.

Indications for Use

Indicated for temporary reconstruction of the mandibular condyle in patients post-resection of malignant or benign tumors. Contraindicated for permanent implantation, patients with TMJ, traumatic injuries, or TMD.

Regulatory Classification

Identification

A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.

Special Controls

*Classification.* Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.

Predicate Devices

• KLS-Martin Temporary Condylar Implant (K990667)
• W. Lorenz Add-On Condyle (K002790)
• Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594)

Submission Summary (Full Text)

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K031701

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## 510(k) Summary

JUL 0 8 2004

| Device Proprietary Name: | OsteoMed Temporary Condylar<br>Attachment System |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Temporary Condylar Implant |
| Classification Name: | Prosthesis, Condylar,<br>Mandibular, Temporary |
| Name of Submitter: | OsteoMed L. P.<br>3885 Arapaho Road<br>Addison, Texas 75001<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | May 25, 2004 |

Summary:

This submission describes the OsteoMed Temporary Condylar Attachment System indicated temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is intended for implantation for no more than one (1) year. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Temporary Condylar Attachment implants are intended for single patient use only.

The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Temporary Condylar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594).

Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Temporary Condylar Attachment System does not raise any new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UUL 0 8 2004

Ms. Dawn T. Holdeman Regulatory Affairs OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K031701

Trade/Device Name: OsteoMed Temporary Condylar Attachment System Regulation Number: 872.3960 Regulation Name: Mandibular Condyle Prosthesis Regulatory Class: III Product Code: NEI Dated: May 25, 2004 Received: May 26, 2004

Dear Ms. Holdeman:

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 such 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.

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Page 2 -- Ms. Holdeman

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 mean that I Drimb mas and regulations administered by other Federal agencies. or the rece of any - with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (27 es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), 11 you donto the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours,

Chin-Lin, Ph.D.

Chiu Lin, Ph.D. 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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## OsteoMed "Indications for Use" Submission

ҚОЗІ701 510(k) Number:

| Device Name: | OsteoMed Temporary Condylar Attachment System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | Indicated for temporary reconstruction of the<br>mandibular condyle in patients who have undergone<br>resective procedures to remove malignant or benign<br>tumors requiring the removal of the mandibular<br>condyle. This device is not intended for permanent<br>implantation, for patients with TMJ or traumatic<br>injuries, or for treatment of temporomandibular joint<br>disease (TMD). Implants are intended for single<br>patient use. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 810.109)

Over-The Counter-Use (Optical Format 1-)

Suver Ruaney

(Division Sign-Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K081170