(76 days)
TiMesh™ System, 1.5/2.0 Combination Titanium Osteosynthesis System, TRAM™
Not Found
No
The device description focuses on the material properties and mechanical function of a titanium mesh for bone stabilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended to stabilize fractures, grafts, and elective osteotomies for the reconstruction of bones, which is a therapeutic purpose.
No
The device is described as a titanium mesh intended to stabilize fractures, grafts, and elective osteotomies, which is a treatment or reconstructive function, not a diagnostic one. It helps reconstruct bones, not identify or analyze a medical condition.
No
The device description clearly states it is a "titanium mesh" and describes its physical properties and how it is attached to bone, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stabilizing fractures, grafts, and osteotomies of the craniomaxillofacial skeleton and oral cavity. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description details a titanium mesh that is surgically implanted and attached to bone with screws. This is consistent with a medical device used for structural support within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural support.
N/A
Intended Use / Indications for Use
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity (including the mandible and maxilla).
Product codes
HRS, JEY
Device Description
The Leibinger® Micro Dynamic Mesh is a titanium mesh available in different shapes, thicknesses, and perforation patterns to treat a variety of clinical applications. The material can be cut with scissors for precision fit, is malleable for three-dimensional adaptations, and is perforated to permit fluid exchange. The mesh is attached to bone by screws. The titanium construction allows for radiological identification but produces negligible artifacts on CT or MRI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton, oral cavity (including the mandible and maxilla)
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)
TiMesh™ System (TiMesh Inc. & Sofamor Danek USA), 1.5/2.0 Combination Titanium Osteosynthesis System (Walter Lorenz) and Osteomed's TRAM™
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 2 3 1998
K9f8332df
510(k) Summary
Proprietary Name: Micro Dynamic Mesh Common Name: Titanium Mesh Classification Name & Reference: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (21 CFR 888.3030) Requiatory Class:
Device Product Code:
Class II HRS
For information contact:
Vivian Kellv Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Phone: (201) 507-7830 Fax: (201) 507-6870
Date Prepared:
October 7, 1998
The Leibinger® Micro Dynamic Mesh is a titanium mesh available in different shapes, thicknesses, and perforation patterns to treat a variety of clinical applications. The material can be cut with scissors for precision fit, is malleable for three-dimensional adaptations, and is perforated to permit fluid exchange. The mesh is attached to bone by screws. The titanium construction allows for radiological identification but produces negligible artifacts on CT or MRI.
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and oral cavity (including the mandible and maxilla).
The substantial equivalence of this device is based on the equivalence in intended use, materials, design, and operational principles to the currently marketed predicate devices such as TiMesh™ System (TiMesh Inc. & Sofamor Danek USA), 1.5/2.0 Combination Titanium Osteosynthesis System (Walter Lorenz) and Osteomed's TRAM™ .
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica, Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070
K983528 Re: Micro Dynamic Mesh Trade Name: Regulatory Class: II Product Code: JEY Dated: October 7, 1998 October 8, 1998 Received:
Dear Ms. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Kelly
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
Sincerel yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Leibinger® Micro Dynamic Mesh
Indications for Use:
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity(including the mandible and maxilla).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_V OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-C Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _