MICRO DYNAMIC MESH

K983528 · Howmedica Corp. · JEY · Dec 23, 1998 · Dental

Device Facts

• Record ID: K983528
• Device Name: MICRO DYNAMIC MESH
• Applicant: Howmedica Corp.
• Product Code: JEY · Dental
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Leibinger Micro Dynamic Mesh is a titanium mesh system used for bone fixation in craniomaxillofacial and oral cavity reconstruction. The device consists of perforated titanium sheets available in various shapes and thicknesses. It is manually shaped by the surgeon to fit the patient's anatomy and cut to size using scissors. The mesh is secured to the bone using screws to stabilize fractures, grafts, or osteotomy sites. The titanium material allows for radiological identification while minimizing artifacts on CT or MRI scans. The device is intended for use by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Titanium mesh; perforated for fluid exchange; malleable for 3D adaptation; cut-to-fit design; secured via bone screws; radiopaque with minimal CT/MRI artifact profile.

Indications for Use

Indicated for stabilization of fractures, grafts, and elective osteotomies in the craniomaxillofacial skeleton and oral cavity (including mandible and maxilla) in patients requiring bone fixation.

Regulatory Classification

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.

Predicate Devices

• TiMesh System (TiMesh Inc. & Sofamor Danek USA)
• 1.5/2.0 Combination Titanium Osteosynthesis System (Walter Lorenz)
• TRAM (Osteomed)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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).

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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 _