KLS-MARTIN TEMPORARY CONDYLAR IMPLANT

K990667 · KLS-Martin L.P. · NEI · Jul 27, 2001 · Dental

Device Facts

• Record ID: K990667
• Device Name: KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
• Applicant: KLS-Martin L.P.
• Product Code: NEI · Dental
• Decision Date: Jul 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin Temporary Condylar Implant is only intended 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 for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

Device Story

Solid condylar head implant; attaches via fastening screws to KLS-Martin Fracture/Reconstruction Plate. Available in left and right configurations. Used by surgeons during mandibular reconstruction procedures following tumor resection. Provides temporary structural support to the mandible. Not intended for permanent use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid condylar head; metallic construction; attaches to fracture/reconstruction plates via screws. Mechanical device; no software or energy source.

Indications for Use

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

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

• Leibinger Temporary Condylar Implant

Submission Summary (Full Text)

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JUL 27 2001

510(K) SUMMARY
(as required by 807.92 9c))

K990667

Submitter of 510(K):

KLS-Martin, L.P.
11239-1 St. Johns Industrial Pkwy. S.
Jacksonville, Florida 32246

Phone:
Fax:

904-641-7746
904-641-7378

Contact Person:

Jennifer Damato

Date of Summary:

July 27, 2001

Trade Name:

KLS-Martin Temporary Condylar Implant

Classification Name:

Temporary Condylar Implant

Predicate Device:

Leibinger Temporary Condylar Implant

Device Description/
Comparison:

The KLS-Martin Temporary Condylar Implant is a solid
condylar head which attaches with fastening screws to a
KLS-Martin Fracture/Reconstruction Plate. The KLS-Martin
Temporary Condylar Implant is available for left and right
placement.

Intended Use:

The KLS-Martin Temporary Condylar Implant is only

joint disease (TMD).

intended 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 for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

JUL 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KLS-Martin L.P. C/O Mr. Arhtur J. Ward Medical Device Consultant Regulatory & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655

K990667 Re : KLS-Martin Temporary Condylar Trade/Device Name: Implant Regulation Number: 872.3960 ırı Requlatory Class: Product Code: NEI Dated: April 27, 2001 Received: April 30, 2001

Dear Mr. Ward:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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

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Page 2 - Mr. Ward

In addition, FDA may publish further announcements action. accron: "In the Federal Register. Please note: this response to your premarket notification submission does ents response or light have under sections 531 through 542 of the Act for devices under the Electronic enrough Siz or on Control provisions, or other Federal laws or regulations.

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 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 "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 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 [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Patricia Crescent//or

Timothy 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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## 610(k) Number (if known): K990667

Device Name: KLS-Martin Temporary Condylar Implant

## Indications For Use:

The KLS-Martin Temporary Condylar Implant is only intended 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 for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Munroe

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K945107

Prescription Use Use (Per 21 CFR 801-109) OR

Over-The-Counter