(183 days)
Not Found
No
The summary describes a customized implant based on CT scans and a "Virtual Implant Design Process" (VIDP), but there is no mention of AI, ML, or related terms. The focus is on the manufacturing process based on surgeon-provided data.
Yes
The device is intended for "augmentation or restoration of bony contour in craniofacial defects," which falls under therapeutic use.
No.
The device is an implant used for augmentation or restoration of bony contour, not for diagnosing a medical condition.
No
The device is a physical implant made of porous high-density polyethylene (HDPE) and is sold as a kit including the implant and a host bone model. While the design process utilizes CT scans, the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "augmentation or restoration of bony contour in craniofacial defects." This describes a surgical implant used directly on the patient's body.
- Device Description: The device is a customized implant molded from porous HDPE and fixed with screws. This is a physical implant, not a test or reagent used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide diagnostic information based on those tests. IVDs are typically used in laboratories or point-of-care settings to analyze biological specimens.
Therefore, the Stryker CMF MEDPOR Customized Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Product codes
FWP
Device Description
The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
Craniofacial
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 CMF MEDPOR Customized Implant was verified and validated according to Stryker procedures for product design and development. Bench testing was performed to demonstrate equivalence of the subject device to the predicate devices. Biocompatibility testing according to ISO 10993-1 was demonstrated by clearance of the predicate devices and in vitro cytoxoxicity testing was performed per 1SO 10993-5. Sterilizations were performed in accordance with ISO 11135, 11137 and 11737; EO residuals testing per ISO 10993-7 and pyrogenicity testing via LAL according to AAMI ST72. Validation of the Virtual Implant Design Process (VIDP) which mirrors the original VIDP Validation (cleared under K103010). Packaging validations and ship testing were performed in accordance with ISO 11607, ASTM F1886, F1929, D642 and F88 to ensure that sterility is maintained throughout the product's labeled shelf life.
No new clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.
0
Traditional 510(k)
NOV
1 2012
Craniomaxiliofacial
Stryker CMF MEDPOR Customized Implant
15 Dart Roud Newnan, G.I 30265 1: 770-254-4400 www.sprcker.com
510(k) Summary
October 5, 2012 Date Prepared: Sponsor/Manufacturer: Howmedica Osteonics Corp. 15 Dart Road Newnan, GA 30265 USA Distributor: Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 USA 510(k) Contact Person: Stephanie Fullard Manager, Regulatory Affairs Howmedica Osteonics Corp. 15 Dart Road Newnan, GA 30265 Phone: (770) 254-4423 Fax: (678) 423-1437 stephanie.fullard@stryker.com Proprietary Name: Stryker CMF MEDPOR Customized Implant Common Name: Porous High Density Polyethylcne (HDPE) Implant Classification Name and Reference: Prosthesis, Chin, Internal, 21 CFR $878.3550 Proposed Regulatory Class: Class II Product Codes: FWP Predicate Devices: MEDPOR Customized Surgical Implant (K083621) Stryker Patient Specific Polymer Implant (K103010) Stryker Patient Specific Polymer Implant (K111065)
1
Stryker CMF MEDPOR Customized Implant
V/12/3/5
20fz
Traditional 510(k)
Device Description:
The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.
Intended Use / Indications for Use:
The Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Technological Characteristics:
The subject device Stryker CMF MEDPOR Customized Implant is a modification of the previously cleared MEDPOR Customized Surgical Implant. The subject device will now be sold as a kit with two sterile implants and a host bone model like the predicate Stryker Patient Specific Polymer Implants. It was determined that none of the modifications impact safety and effectiveness.
Performance Data:
The Stryker CMF MEDPOR Customized Implant was verified and validated according to Stryker procedures for product design and development. Bench testing was performed to demonstrate equivalence of the subject device to the predicate devices. Biocompatibility testing according to ISO 10993-1 was demonstrated by clearance of the predicate devices and in vitro cytoxoxicity testing was performed per 1SO 10993-5. Sterilizations were performed in accordance with ISO 11135, 11137 and 11737; EO residuals testing per ISO 10993-7 and pyrogenicity testing via LAL according to AAMI ST72. Validation of the Virtual Implant Design Process (VIDP) which mirrors the original VIDP Validation (cleared under K103010). Packaging validations and ship testing were performed in accordance with ISO 11607, ASTM F1886, F1929, D642 and F88 to ensure that sterility is maintained throughout the product's labeled shelf life.
No new clinical testing was required.
Substantial Equivalence:
The Stryker CMF MEDPOR Customized Implant is substantially equivalent to the predicate devices identified above in terms of indications, materials, design and operational principles. The Stryker CMF MEDPOR Customized Implant has been verified and validated according to Stryker procedures for product design and development. The information presented in this submission supports substantial equivalence of the Stryker CMF MEDPOR Customized Implant to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV
Howmedica Osteonics, Corporation % Ms. Stephanie Fullard Manager, Regulatory Affairs 15 Dart Road Newnan, Georgia 30265
Re: K121315
Trade/Device Name: Stryker® CMF MEDPOR Customized Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin prosthesis Regulatory Class: Class II Product Code: FWP Dated: October 05, 2012 Received: October 09, 2012
Dear Ms. Fullard:
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.
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
1 2012
3
Page 2 - Ms. Stephanie Fullard
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S 2012.11.01 15:37:19 -04'00'
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Stryker CMF MEDPOR Customized Implant
Traditional 510(k)
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stryker® CMF MEDPOR Customized Implant
Indications for Use:
The Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Prescription Use X : (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Director)
(Division Sign-Off) Division of Surgical, Orthopedic, and Kestorative Devices
510(k) Number K121315
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