(66 days)
Not Found
No
The description focuses on converting CT data to 3D images and anatomical models for custom implant creation, which is a standard process for patient-specific implants and does not explicitly mention or imply the use of AI or ML algorithms for analysis, decision-making, or design optimization.
Yes
The device is designed to correct trauma and/or defects in bones, which is a therapeutic application.
No.
The device is described as an implant designed to correct trauma and/or defects, not a device that diagnoses medical conditions.
No
The device description explicitly states it is a "titanium-mesh implant" and describes its manufacturing process, indicating it is a physical hardware device, not software only.
Based on the provided information, the Stryker® Custom Ti Implant is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Stryker® Custom Ti Implant Function: This device is a physical implant designed to be surgically placed within the patient's body to correct bone defects. It uses patient imaging data (CT scans) to create a custom-fit physical object, not to analyze biological specimens.
The process described involves using imaging data to design and manufacture a physical medical device for surgical implantation, which falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect. This implant will utilize patient C.T. scan data to produce a custom-contoured titanium or titanium mesh implant that optimally fits each patient. The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images. These images are used to create anatomical models which are then used to build the customized implant.
The implant will be designed and molded for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
The Stryker® Custom Ti Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Product codes
GXN
Device Description
The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect.
Mentions image processing
The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient C.T. scan data
Anatomical Site
mandibular, maxillofacial, or craniofacial bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVE
Stryker® Custom Ti Implant
General Information
DEC 1 6 2005
| Proprietary Name: | Stryker® Custom Ti Implant |
|---|---|
| Common Name: | Preformed Plate |
| Proposed Regulatory Class: | Class II |
| Device Classification: | GXN (21 CFR 882.5330) |
| Plate, Cranioplasty, Preformed, Non-Alterable | |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 269-323-4226 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie |
| Manager, RA/QA | |
| Phone: 269-323-4226 | |
| Fax: | |
| 269-323-4215 | |
| Summary Preparation Date: | October 4, 2005 |
Intended Use
The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect. This implant will utilize patient C.T. scan data to produce a custom-contoured titanium or titanium mesh implant that optimally fits each patient. The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images. These images are used to create anatomical models which are then used to build the customized implant.
Substantial Equivalency Information
The Stryker® Custom Ti Implant is substantially equivalent to the Stryker Custom Cranial Implant (K043250) and Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868). The Stryker Custom Ti Implants will be manufactured using the same method as the Stryker Custom Cranial Implant (K043250) using titanium or titanium mesh similar to the Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868).
The implant will be designed and molded for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human figures inside of it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2005
Mr. Wade T Rutkoskie Stryker Leibinger 4100 East Milham Ave Kalamazoo, Michigan 49001
Re: K052871
Trade/Device Name: Stryker Custom Ti Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Plate, Cranioplasty, Preformed, non-alterable Regulatory Class: II Product Code: GXN Dated: November 9, 2005 Received: November 22, 2005
Dear Mr. Rutkoskie:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nare reviewed 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 for use sured in the energy, 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 r ou may a 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 (PMA), 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 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); 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.
2
Page 2 - Wade Rutkoskie
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Milliken
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K052871/S
Page 1 of 1
510(k) Number (if known): K
Device Name: Stryker Custom Ti Implant
Indications For Use:
The Stryker® Custom Ti Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Prescription Use
(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 NEFIDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Mark A. Millerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page / of /
~10(k) Number
(Posted November 13, 2003)