(14 days)
Not Found
No
The description focuses on a pre-formed implant based on CT scans, with no mention of AI or ML in the device description, intended use, or performance studies. The process appears to be a direct mapping from CT data to implant shape, not an AI/ML-driven analysis or decision-making process.
No
The device is a pre-formed plate designed to correct trauma and defects in bone, thus serving as a structural implant rather than a device that delivers therapy.
No
The device is described as an implant used to correct trauma and defects, not to identify or determine a medical condition.
No
The device description explicitly states it is a "pre-formed plate made of cured Simplex P bone cement," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Stryker® Patient Specific Polymer Implant is a physical implant designed to correct bone defects. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to correct trauma and/or defects in bone, not to analyze biological samples for diagnostic purposes.
- Input: The input is CT scans, which are used for planning and manufacturing the implant, not for analyzing biological samples.
The device description and intended use clearly indicate that this is a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Product codes (comma separated list FDA assigned to the subject device)
KKY, GWO
Device Description
The Stryker® Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
mandibular, maxillofacial, or craniofacial bone
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)
Testing has been performed to demonstrate equivalence of the subject sterile devices to the predicate nonsterile devices. The testing includes sterilization via ISO 11137-2, and pyrogenicity testing via the LAL test according to ANSI/AAMI ST72:2002. Bioburden testing was conducted to ISO 11137-2. The packaging has been validated to ensure that sterility is maintained throughout the product's labeled shelf life of 6 months.
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
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.
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K103010 page 1/2
510(k) Summary of Safety and Effectiveness:
Stryker® Patient Specific Polymer Implant
OCT 2 6 2010
| Proprietary Name: | Stryker® Patient Specific Polymer Implant |
|---|---|
| Common Name: | Preformed Alterable Cranioplasty Plate , PMMA |
| Classification Name and Reference: | Polytetrafluoroethylene with carbon fibers composite implant |
| material, 21 CFR §878.3500 | |
| Preformed alterable cranioplasty plate 21 CFR §882.5320 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | KKY, GWO |
| For Information contact: | Stephanie M. Fitts, PhD |
| Director, Regulatory Affairs and Regulatory Compliance | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5405 Fax: (201) 831-4405 | |
| Date Prepared: | October 8, 2010 |
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K103010 Page 2/2
Description:
This Special 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Stryker® Patient Specific Polymer Implant components in a sterile fashion.
Intended Use:
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Proposed Modification:
The product will now be supplied sterile via gamma radiation in packaging that has been validated to maintain sterility throughout the product's labeled shelf-life. The manufacturing location will change from the contract manufacturer to Stryker. Although the manufacturing process has not changed since originally described in K043250, newer versions of the commercially available software described in the original submission (Materialise software) have been integrated into the process with full validation.
Device Description:
The Stryker® Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
Summary of Data:
Testing has been performed to demonstrate equivalence of the subject sterile devices to the predicate nonsterile devices. The testing includes sterilization via ISO 11137-2, and pyrogenicity testing via the LAL test according to ANSI/AAMI ST72:2002. Bioburden testing was conducted to ISO 11137-2. The packaging has been validated to ensure that sterility is maintained throughout the product's labeled shelf life of 6 months.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation. % Stephanie M. Fitts, PhD Director, Regulatory Affairs and Regulatory Compliance 325 Corporate Drive Mahwah, New Jersey 07430
oci 2 6 2010
Re: K103010
Trade/Device Name: Stryker® Patient Specific Polymer Implant Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY, GWO Dated: October 8, 2010 Received: October 12, 2010
Dear Dr. Fitts:
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. Iisting 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.
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
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Page 2 - Stephanie M. Fitts, PhD
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.htm 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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Stryker® Patient Specific Polymer Implant
Special 510(k)
OCT 2 6 2010
KID3010
Indications for Use
510(k) Number (if known): K103010
Device Name: Stryker® Patient Specific Polymer Implant
Indications for Use:
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daind Keane for MXM
(Division Sign-Off)
Page 1 of 1
Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K103010
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