(88 days)
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Not Found
No
The description focuses on the physical components and intended use of a resorbable fixation system, with no mention of AI or ML capabilities.
Yes
The device is intended for the fixation of bones affected by trauma or for reconstruction, which are therapeutic interventions.
No
The device is a resorbable fixation system (plates and screws) used for the physical fixation of bones in the craniofacial and midfacial skeleton, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of physical components like plates, mesh, and screws, which are hardware.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a system of plates, mesh, and screws intended for the fixation of bones in the craniofacial and midfacial skeleton. This is a surgical implant used directly on the patient's body, not for testing samples outside the body.
The device is a surgical implant used for bone fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Howmedica Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients, but is not intended for use in the mandible and/or full load bearing procedures.
Product codes
MAI, HWC, HRS
Device Description
The Howmedica Leibinger Resorbable Fixation system consists of a series of plates and mesh in varying configurations and lengths which are attached to the bone using screw fixation. The plates are available in two thicknesses (1.0mm and 1.5mm). The mesh is also available in two thicknesses (0.7mm and 1.2mm). Additionally, there are two screw diameters of 1.5mm and 2.0mm and a third emergency screw with a 2.5mm diameter. These plates and screws are intended for use in the fixation bones of the craniofacial and midfacial skeleton affected by trauma or for The plates and mesh can be contoured by heating. reconstruction. The system can be used in both adult and pediatric patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniofacial and midfacial skeleton
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Testing was performed to demonstrate an equivalence in performance to the LactoSorb Trauma Plating System (Walter Lorenz subsidiary of Biomet).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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OCT 16 1998
510 (k) Summary
| Trade Name: | Howmedica Leibinger Resorbable
Fixation System |
|----------------------|----------------------------------------------------------------|
| Common Name: | Small Bone Plating System |
| Classification Name: | Smooth or Threaded Metallic Bone
Fixation Fastener 888 3040 |
The Howmedica Leibinger Resorbable Fixation system consists of a series of plates and mesh in varying configurations and lengths which are attached to the bone using screw fixation. The plates are available in two thicknesses (1.0mm and 1.5mm). The mesh is also available in two thicknesses (0.7mm and 1.2mm). Additionally, there are two screw diameters of 1.5mm and 2.0mm and a third emergency screw with a 2.5mm diameter. These plates and screws are intended for use in the fixation bones of the craniofacial and midfacial skeleton affected by trauma or for The plates and mesh can be contoured by heating. reconstruction. The system can be used in both adult and pediatric patients.
The substantial equivalence of this device is based on similarities in intended use, design and operational principles to the LactoSorb Trauma Plating System (Biomet) and the Luhr® Pan Fixation System (Howmedica). The material used in the manufacture of the Howmedica Leibinger Resorbable Fixation System is substantially equivalent to that used in the LactoSorb Device. Testing was performed to demonstrate an equivalence in performance to the LactoSorb Trauma Plating System (Walter Lorenz subsidiary of Biomet).
The basic operational principles for the use of small bone plating systems is similar for the Howmedica Leibinger Resorbable Fixation System, The LactoSorb Trauma Plating System and The Luhr® Pan Fixation System, that is to provide stabilization and fixation of small bones of the craniofacial and midfacial skeleton due to fracture or osteotomy. The method of site preparation, relative indications and contraindications is similar for the Howmedica System and the LactoSorb System.
For information contact: John Dichiara
Director, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Phone (201) 507-7386 Fax (201) 507-6870
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Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
OCT 16 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
к982531 Re : Trade Name: Howmedica Leibinger Resorbable Fixation System Regulatory Class: II Product Codes: MAI, HWC, and HRS Dated: July 17, 1998 Received: July 20, 1998
Dear Mr. Dichiara:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John F. Dichiara
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (k) Number (if known): Not Known
Howmedica Leibinger Resorbable Fixation System Device Name:
Indications for Use:
The Howmedica Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients, but is not intended for use in the mandible and/or full load bearing procedures.
(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)
bally
Pivisio