(28 days)
The Titanium Pediatric Femoral Nail is indicated for fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures.
Intramedullary rods (nails) are generally rod-shaped devices, with or without screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary (bone marrow) canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. This device is made of titanium 6AL-4V alloy.
This document is a 510(k) premarket notification for a medical device (Titanium Pediatric Femoral Nail) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical safety and effectiveness through a new clinical trial with specific performance metrics.
Therefore, I cannot extract the requested information from the provided text, as it doesn't exist within this document. The document primarily focuses on:
- Device Description: What the device is and its intended use.
- Potential Risks: General risks associated with this type of device.
- Substantial Equivalence Argument: How this device is similar to previously cleared devices (stainless steel rods and other titanium intramedullary rods).
- FDA Clearance Letter: Formal statement from the FDA that the device is substantially equivalent and can be marketed.
- Indications for Use: The specific medical conditions for which the device is intended.
To answer your questions, one would typically look for a clinical study report or a different type of regulatory submission (like a PMA, which requires clinical data to demonstrate safety and effectiveness).
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DEC 2 0 1999
Summary of Safety and Effectiveness Information
Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46580
Device: Titanium Pediatric Femoral Nail
Classification Name: Rod, Fixation, Intramedullary and Accessories (21 CFR 888.3020)
Device Description: Intramedullary rods (nails) are generally rod-shaped devices, with or without screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary (bone marrow) canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. This device is made of titanium 6AL-4V alloy.
Potential Risks: The risks associated with this device are the same as with any metallic internal fixation device. These include, but are not limited to the following:
Delayed or non-union that may lead to breakage of the implant
Bending, fracture, or migration of the implant
Metal sensitivity, or allergic reaction to a foreign body
Limb shortening, or decrease in bone density, due to compression of the fracture or bone resorption
Pain, discomfort, or abnormal sensations due to the presence of the device
Nerve damage due to surgical trauma
Necrosis of bone
Infection
Hematoma
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Substantial Equivalence: In function and overall design, titanium intramedullary rods (nails) are equivalent to stainless steel rods that have been widely used for fracture fixation of long bones since the 1960's. In addition, a wide variety of titanium intramedullary rods (nails) were cleared for commercial distribution under Biomet 510(k) number K982953 for use in the femur, tibia, fibula, humerus, radius, and ulna.
Biomet/OEC Stainless Steel Flexible Nails Biomet Titanium Intramedullary Rods (K982953)
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
DEC 2 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lonnie Witham Senior Regulatory Affairs Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
K993956 Re: Trade Name: Titanium Pediatric Femoral Nail Regulatory Class: II Product Code: HSB Dated: November 12, 1999 Received: November 22, 1999
Dear Ms. Witham:
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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 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 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.
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.
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Page 2 - Ms. Witham
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) 594-4595. 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,
Neil RPOgden
James E. Dillard III for
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number_ K993956 _______________________________________________________________________________________________________________________________________________________
Device Name: Titanium Pediatric Femoral Nail
Indications for Use:
The Titanium Pediatric Femoral Nail is indicated for fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures.
(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) |
|---|---|---|---|
| Division Sign Off | DRO for | ||
| Division | |||
| 510(k) Number | K93956 |
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.