(106 days)
The indications for use of the MODUS® 2.5 Reconstruction Set include reconstruction surgery, including bone grafting and bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.
The MODUS® 2.5 Mandibular Reconstruction Set is a complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories.
This document is a 510(k) summary for the MODUS® 2.5 Mandibular Reconstruction Set, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your bullet points (acceptance criteria, study details, sample sizes, expert involvement, MRMC study, standalone performance, ground truth, training set) is typically not found in a 510(k) submission for this type of device (a Class II orthopedic implant).
Instead, 510(k) summaries for devices like this primarily focus on:
- Description of the Device: What it is made of, its components, and how it works.
- Intended Use: The medical conditions it is meant to treat.
- Comparison to Predicate Devices: How it is similar and different from previously cleared devices, and why these differences do not raise new questions of safety and effectiveness.
- Performance Data: Often non-clinical data (e.g., mechanical testing, materials testing) to demonstrate that the new device performs as intended and is equivalent to predicate devices. For orthopedic implants, this often involves fatigue testing, strength testing, and biocompatibility testing.
There is no information within the provided text about acceptance criteria, clinical study results, sample sizes for test or training sets, ground truth establishment, or expert reviews as these would be found in a clinical trial report. The document states that the device is "substantially equivalent" to predicate devices based on its design and intended use.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is essentially a regulatory clearance letter, not a detailed clinical study report.
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ATTACHMENT 7 - 510(k) Summary
1. Applicant's Name and Address
Straumann USA (on behalf of Medartis, GmbH) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: Fax Number: 781-890-6464 Contact Person: Linda Jalbert, Director of Regulatory Affairs
2. Name of the Device
| Trade Name: | MODUS® 2.5 Mandibular ReconstructionSystem |
|---|---|
| Common Name: | Craniofacial fixation system |
| Classification Name: | Multiple component bone fixation metallicappliances(21 CFR 888.3030) |
3. Devices to which Equivalence is Claimed Legally Marketed (Predicate Devices)
MODUS® Titanium Osteosynthesis System (K946165) Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System Synthes® Mandibular Modular Fixation System (K954385) Synthes - 2.4 Mandibular Fracture Set (K961421) Stryker® Leibinger TITANIUM Locking Screw Mandibular Reconstruction Plating System
4. Description of the Device
The MODUS® 2.5 Mandibular Reconstruction Set is a complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories.
റ്. Intended Use of the Device
The indications for use of the MODUS® 2.5 Reconstruction Set include reconstruction surgery, including bone grafting and bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.
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6. Basis for Substantial Equivalence
The MODUS® 2.5 Reconstruction Set is substantially equivalent to the MODUS® System previously cleared in K946165. The MODUS® 2.5 Reconstruction Set is also substantially equivalent to the Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System, the Synthes® Mandibular Modular Fixation System and Universal Locking Plate System, and the Stryker® Leibinger TITANIUM Locking Screw Mandibular Reconstruction Plating System.
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Image /page/2/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 image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 2 4 1999
Medartis c/o Ms. Linda Jalbert Medartis Director, Requlatory Affairs Straumann USA 1601 Trapelo Road Reservoir Place Waltham, MA 02451
Re : K992682 MODUS 2.5 Mandibular Reconstruction Set Trade Name: Requlatory Class: II Product Code: JEY Dated: November 9, 1999 November 10, 1999 Received:
Dear Ms. Jalbert :
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 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, Druq, 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 aqainst 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Ms. Jalbert
the Federal Register. Please note: this response to your ene relet notification submission does not affect any obligation you might have under sections 531 through 542 of obligation our mass under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 markees 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 ritro 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 ene regaranotification" (21 CFR 807.97). Other general 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.fdaf.gov/cdrh/dsmamain.html".
Sincerely 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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Paqe
of
K992682 510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
MODUS® 2.5 Mandibular Reconstruction Set DEVICE NAME:
INDICATIONS FOR USE:
The indications for use of the MODUS® 2.5 Reconstruction Set include use in The indications for use of the MODOD & E.S. Resort bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma, e.g. tunstable, comminuted mandibular fractures and bone loss.
(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)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Runo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices and 510(k) Number_
§ 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.