(71 days)
Not Found
No
The summary describes a mechanical plate and screw system for bone fixation and makes no mention of AI or ML.
Yes
The device is described as "intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction," which directly indicates a therapeutic purpose.
No
Explanation: The device is described as a "mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction." This indicates a therapeutic or reconstructive purpose, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a "mandibular plate and screw system," which are physical hardware components used for surgical fixation.
Based on the provided information, the Stryker Leibinger NewGen System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization and rigid fixation of mandibular fractures and reconstruction. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: It's described as a "mandibular plate and screw system," which are physical implants used in surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the Stryker Leibinger NewGen System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Leibinger NewGen System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
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.
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
8 2002 MAR 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
NewGen/Universal Mandibular System
General Information
| Proprietary Name: | NewGen/Universal Mandibular 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 x3295 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Robin L. Rowe |
| Regulatory Affairs Representative | |
| Phone: 616-323-7700 x3295 | |
| Fax: 616-324-5412 | |
| Summary Preparation Date: | November 22, 2000 |
Intended Use
The Stryker Leibinger NewGen System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
Substantial Equivalence
EQUIVALENT PRODUCTS:
The Leibinger® NewGen/Universal System is substantially equivalent to the NewGen System K002619 which is a legally marketed devices.
Robin J. Rowe
Regulatory Affairs Representative
Regulatory Affairs Representative December 20, 2001
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Ms. Robin L. Rowe Regulatory Affairs Stryker Instruments 4100 East Milham Avenue Kalamazo, Michigan 49001-6197
Re: K014263
Trade/Device Name: Newgen/Universal Mandibular System Regulation Number: 872.4760 Regulation Name: Bone Plates, Bone Fixation System Regulatory Class: II Product Code: JEY Dated: February 6, 2002 Received: February 7, 2002
Dear Ms. Rowe:
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.
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.
2
Page 2 - Ms. Rowe
You must comply with all the Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF R Pat 807), and 1007), and in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality signify systems (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 This letter will and w you to began mans and substantial equivalence of your device to 310(K) premierse notificate 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 If you desire up of CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 OF 1 301) 594-4613. Additionally, for questions on the promotion and Office of Comphance are, 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 ulle Act may of occallied 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
Tim A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Page 1 of 1
510(k) Number (if known):
Device Name: Newgen/Universal Madibular System
Indication For Use:
The Stryker Leibinger Newgen/Universal Mandibular System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH,Office of device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Svea Summo
Division Sign Off
or
ivision Sign-Off ivision of Dental, Infection Control. nd General Hospital Devices 510(k) Number