(105 days)
Not Found
No
The 510(k) summary describes a mechanical plate and screw system for craniofacial fixation and makes no mention of AI or ML.
No.
The device is a plate and screw system for rigid fixation of fractures and reconstruction, which are surgical tools or implants, not devices typically classified as therapeutic in the sense of actively treating or curing a disease through therapeutic modalities.
No.
The device is a plate and screw system for surgical fixation and reconstruction, not for identifying diseases or conditions.
No
The device description clearly states it is a "low-profile 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Stryker® Leibinger Universal Neuro System clearly state it is a plate and screw system used for surgical procedures (osteotomy, craniotomy, fixation of fractures, reconstruction) on the craniofacial bones. This is a surgical implant/device, not a diagnostic test performed on samples.
The information provided about the device's function and application is entirely focused on surgical intervention and structural support, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
76 JEY, 87 HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
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.
K022185 Universal CMF System, K924138 Osteomed M 3 System, K023260 Osteomed 1.2 mm Autodrive Screw System, K022012 Synthes Low Profile Neuro System.
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
§ 872.4760 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
K03/659
SEP. 1 0 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® Leibinger Universal Neuro System
General Information
| Proprietary Name: | Stryker® Leibinger Universal Neuro 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 | |
| 269-323-4226 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie |
| Associate Manager RA QA | |
| Phone: 269-323-4226 | |
| Fax: 269-323-4215 | |
| Summary Preparation Date: | May 20, 2003 |
Intended Use
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction.
Substantial Equivalency Information
The Stryker® Leibinger Universal Neuro System is substantially equivalent to legally marketed K022185 Universal CMF System, K924138 Osteomed M 3 System, K023260 Osteomed 1.2 mm Autodrive Screw System, and K022012 Synthes Low Profile Neuro System.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K031659
Trade/Device Name: Sryker® Leibinger Universal Neuro System Bone Plates and Bone Fixation Fasteners Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 20, 2003 Received: June 17, 2003
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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,
Susan Runs
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(K) Number (if known): K031659
Device Name: Stryker® Leibinger Universal Neuro System
Indication for Use:
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.
Kein Mulvey for MSA
y, General Hospital, n of Anesthesiolo ion Control, Den
510(k) Number: K031659
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (per 21 CFR 801.109) |
Over-The-Counter Use
(Optional Format 1-2-96)