(58 days)
Not Found
Not Found
No
The 510(k) summary describes a purely mechanical implant (intramedullary rod) and makes no mention of any software, algorithms, or AI/ML capabilities.
No
The device is used for alignment, stabilization, and fixation of fractures and deformities in long bones, which are structural and mechanical functions, not therapeutic.
No
The device description clearly states its purpose is for "alignment, stabilization and fixation of fractures" and "fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis." These are therapeutic and structural functions, not diagnostic.
No
The device description clearly states it is an intramedullary rod made of titanium alloy, which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is an "Intramedullary rod" made of titanium alloy, intended to be "implanted into the long bones" for "alignment, stabilization and fixation of fractures."
- Intended Use: The intended use is for surgical implantation within the body to treat bone fractures and deformities.
There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis. The device is a surgical implant used for mechanical support and fixation.
N/A
Intended Use / Indications for Use
Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
Intramedullary rods are generally rod-shaped devices with or without screw holes at either end for fixation to bone. These devices are intended to be inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures by aligning and stabilizing the bone fragments. Intramedullary rods are also used to align and stabilize long bones which are surgically cut (osteotomy) to correct deformity. Additional stabilization may be realized by installing transverse screws through holes in the rod. Intramedullary rods and transverse screws are made of titanium 6Al-4V alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, fibula, humerus, radius, and ulna
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K982953 10f2
OCT 2 | 1998
Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font. The logo is simple and professional, and it conveys a sense of stability and reliability.
Summary of Safety and Effectiveness
Sponsor. Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581
Device. Titanium Intramedullary Rods - Various Styles
Classification Name. Rod, Fixation, Intramedullary and Accessories (CFR 888.3020)
Device Description. Intramedullary rods are generally rod-shaped devices with or without screw holes at either end for fixation to bone. These devices are intended to be inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures by aligning and stabilizing the bone fragments. Intramedullary rods are also used to align and stabilize long bones which are surgically cut (osteotomy) to correct deformity. Additional stabilization may be realized by installing transverse screws through holes in the rod. Intramedullary rods and transverse screws are made of titanium 6Al-4V alloy.
Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
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 nonunion which may lead to breakage of the implant
Bending or fracture of the implant
Loosening 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
MAILING ADDRESS PO Box 587 - P.O. Box 587
Warsaw, IN 46581-0587 - - - -
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
행
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.cor000093
1
Kag, 2453 20f2
Nerve damage due to surgical trauma
Necrosis of bone
Infection
((
Hematoma
Substantial Equivalence. In function and overall design, titanium intramedullary rods are equivalent to stainless steel intramedullary rods which have been widely used for fracture fixation in long bones since the 1960s.
. . . . . . . . .
Grosse Kempf System (Howmedica) Intramedullary Nails (Zimmer) Kirschner Intramedullary Nail System (now Biomet, Inc.) OEC Kuntscher Cloverleaf Nail Systems (now Biomet, Inc.)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side, and a stylized emblem on the right. The emblem features a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Mr. Lonnie Witham 6enior Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K982953 Titanium Intramedullary Nails - Various Styles Regulatory Class: II Product Code: HSB Dated: August 18, 1998 Received: August 24, 1998
Dear Mr. 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 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 requlation 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 requlations.
3
Page 2 - Mr. Lonnie Witham
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) 594-4659. 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. Whitton, Ph.D., M.D.
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
4
510(k) Number: K982953
Device Name: Titanium Intramedullary Nails
Indications For Use: Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
(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) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982953 |
|---|---|
| --------------- | --------- |
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