(166 days)
Not Found
No
The summary describes a mechanical implant and its testing, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a "Temporary Condylar Prosthesis" intended for physical reconstruction following tumor surgery, not for treating a disease or condition.
No
This device is a prosthesis intended for temporary reconstruction of the mandibular condyle after tumor removal, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a physical prosthesis made of titanium with a PVD coating, accompanied by connecting screws. It also details mechanical and biocompatibility testing of the physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary reconstruction of the mandibular condyle during surgery. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical prosthesis made of titanium, designed to be implanted in the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
Therefore, based on the provided information, the Stryker Temporary Condylar Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular condyle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4770 Temporary mandibular condyle reconstruction plate.
(a)
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.(b)
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.
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: 269-389-4260 Fax: 877-648-7114 jamshed.badarpura@stryker.com
Date Prepared:
October 24, 2013
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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
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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
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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.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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'
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