(167 days)
Not Found
No
The 510(k) summary describes a traditional plate and screw system for bone fixation and does not mention any AI/ML components or functionalities.
No
The device is described as a plate and screw system for stabilizing and fixing fractures, which falls under surgical repair rather than therapeutic treatment.
No
Explanation: The device is a plate and screw system for fixing CMF fractures and reconstruction, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "plate and screw system," which are physical hardware components used for surgical fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction." This describes a surgical implant used in vivo (within the body) to treat physical injuries.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information about a person's health. They are used in vitro (outside the body).
The Stryker® Leibinger Universal CMF System is a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.
Product codes
JEY, HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranio-maxillofacial (CMF)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K014263, K002619, K862482, K854886, K953806, K993862, K862532
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
DEC 1 7 2002
KODASS
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Universal CMF System
General Information
| Proprietary Name: | Universal CMF System |
|---|---|
| Common Name: | Bone Plates |
| Bone Fixation Fasteners | |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 76 JEY |
| 87 HWC | |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 616-323-7700 x4226 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie |
| Regulatory Affairs Associate | |
| Phone: 616-323-4226 | |
| Fax: | |
| 616-323-4215 | |
| Summary Preparation Date: | June 28, 2002 |
Intended Use
The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.
Substantial Equivalence
EQUIVALENT PRODUCTS:
The Stryker® Leibinger Universal CMF System is substantially equivalent to legally marketed K014263 NewGen Mandibular System, K002619 NewGen System , K862482 Steinhauser Titanium Mini Bone Plates & Screws, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthes Midfacial System, K993862 MODUS® Titanium Osteosynthesis System and K862532 Dumbach Titanium Mesh Implant System.
Nudy T. Rutkuski
Wade T. Rutkoskie Regulatory Affairs Associate
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2002
Mr. Wade Rutkoskie Regulatory Affairs Associate Stryker Instruments Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49087
Re: K022185
Trade/Device Name: Universal CMF System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 30, 2002 Received: October 4, 2002
Dear Mr. Rutkoskie:
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.
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.
2
Page 2 - Mr. Rutkoskie
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.
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Page 1 of 1
510(k) Number (if known)
Device Name: Universal CMF System
Indication For Use:
The Stryker® Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. 1 .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
| Prescription Use | ✓ | or | Over-The-Counter Use | |
|---|---|---|---|---|
| (per 21 CFR 801.109) | ||||
| Susan Runne | ||||
| (Division Sign-Off) | (Optional Format 1-2-96) | |||
| Division of Anesthesiology, General Hospital, | ||||
| Infection Control, Dental Devices | ||||
| 510(k) Number: | K022155 |