STRYKER TEMPORARY CONDYLAR PROSTHESIS

K133285 · Stryker · NEI · Apr 9, 2014 · Dental

Device Facts

• Record ID: K133285
• Device Name: STRYKER TEMPORARY CONDYLAR PROSTHESIS
• Applicant: Stryker
• Product Code: NEI · Dental
• Decision Date: Apr 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle.

Device Story

Stryker Temporary Condylar Prosthesis is a solid condylar head component for mandibular reconstruction; rigidly connected to standard or locking reconstruction plates via titanium alloy screws. Device is provided in left and right configurations. Modification involves a new PVD (Physical Vapor Deposition) coating on the condylar head, providing a golden color. Used by surgeons in clinical settings for patients undergoing ablative tumor surgery. Device serves as a temporary structural replacement for the mandibular condyle for up to 24 months, facilitating reconstruction post-tumor resection.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing included friction behavior, surface roughness, coating thickness, wear resistance, adhesion strength, hardness, biocompatibility, and corrosion resistance to ensure mechanical integrity and safety of the modified coating.

Technological Characteristics

Commercially pure titanium condylar head with PVD coating; commercially pure titanium alloy connecting screws. Design and dimensions identical to predicate. Mechanical fixation to reconstruction plates. Non-active, implantable device.

Indications for Use

Indicated for patients undergoing ablative tumor surgery requiring removal of the mandibular condyle, for temporary reconstruction not exceeding 24 months.

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

• Locking Reconstruction Plate with Attachable Condylar Head (K020199)

Submission Summary (Full Text)

{0}------------------------------------------------

# APR 0 9 2014 stryker"

750 Trade Centre Way Suite 200 Portage, M1 49002 t: 269 324 5346 f: 877 648 7114 www.stryker.com

## 510(k) Summary of Safety and Effectiveness:

## Stryker Temporary Condylar Prosthesis

Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 79111 Freiburg, Germany

Proprietary Name:

Common Name:

Sponsor:

Stryker Temporary Condylar Prosthesis

21 CFR §872.4770 - Temporary mandibular

Temporary mandibular condyle reconstruction plate

condyle reconstruction plate

Classification Name and Reference:

Regulatory Class:

Device Product Code(s):

Predicate devices:

510(k) Contact Person:

Class II

NEI

사

K020199 - Locking Reconstruction Plate with Attachable Condylar Head

Jamshed Badarpura Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 Phone: [phone] Fax: [phone] [e-mail]

Date Prepared:

October 24, 2013

Page 1 of 3

{1}------------------------------------------------

## Introduction:

A Traditional 510(k) is being submitted to the FDA to grant clearance to market the Stryker Temporary Condylar Prosthesis cleared via K020199 with the proposed modification.

#### Proposed Modification:

Change in material composition of coating used on the head of Stryker Temporary Condylar Prosthesis.

### Intended Use:

Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative turnor surgery requiring removal of the mandibular condyle.

#### Device Description:

The Stryker Temporary Condylar Prosthesis is an independent solid condylar head which is rigidly connected to a standard or locking Stryker Reconstruction plate via fastening screws. The Temporary Condylar Prosthesis is provided in a left and right configuration and is intended for temporary use only (not exceeding 24 months). The Condylar Prosthesis is made of commercially pure titanium and the head of the condyles is PVD (Physical Vapor Deposition) coated which differentiates it from the rest of the condyles giving it golden color. The Temporary Condylar Prosthesis is accompanied by connecting screws which are made of commercially pure titanium alloy and are specifically designed to fixate the Prosthesis with a Stryker plate.

### Technological Characteristics:

The subject Stryker Temporary Condylar Prosthesis when provided with the new coating material will have very similar technological characteristics as its originally cleared predicate version. The Temporary Condylar Prosthesis will have the exact same design and dimensions, and will be fabricated from commercially pure titanium. The connecting screws will also remain unchanged with respect to design and material composition. The

Page 2 of 3

{2}------------------------------------------------

only difference in the subject condyles from its earlier version will be difference in material composition of the coating material on head of the condyles.

## Summary of Performance Testing:

The Stryker Temporary Condylar Prosthesis was subject to Verification and Validation testing to ensure that the new coating is safe and effective, and the design outputs of the modified device meets the design inputs of the originally cleared device. Various tests like friction behavior, roughness, thickness, wear resistance, adhesion strength and hardness were conducted to verify mechanical wear and integrity of the new coating material. Additionally, biocompatibility and corrosion tests were performed to ensure that the new coating material is biocompatible and corrosion resistant.

## Substantial Equivalence:

The Stryker Temporary Condylar Prosthesis is substantially equivalent to its originally cleared version (predicate) with regards to Intended Use, design, principle material composition and operational principle. Further, results from performance testing confirm that the difference in material composition of coating material does not affect the safety and effectiveness of the device.

## Predicate Device -

Locking Reconstruction Plate with Attachable Condylar Head - K020199

Page 3 of 3

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 9, 2014

Stryker Leibinger GmbH & CO. KG C/O Mr. Jamshed Badarpura Stryker Craniomaxillofacial 750 Trade Centre Way Suite 200 Portage, MI 49002 US

Re: K133285

> Trade/Device Name: Stryker Temporary Condylar Prosthesis Regulation Number: 21 CFR 872.4770 Regulation Name: Temporary Mandibular Condyle Reconstruction Plate Regulatory Class: Class II Product Code: NEI Dated: March 20, 2014 Received: March 20, 2014

Dear Mr. Badarpura:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{4}------------------------------------------------

#### Page 2 - Mr. Badarpura

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 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.qov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

{5}------------------------------------------------

## Indications for Use ·

510(k) Number (if known): K133285

Stryker Temporary Condylar Prosthesis

Indications for Use:

Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2014.04.08 09:16:28 -04'00'

Page 1 of 1