(90 days)
Not Found
No
The description focuses on the mechanical design and function of an intramedullary nail for fracture fixation, with no mention of AI or ML capabilities.
No
Explanation: The device is used for the fixation of fractures and bones, not for providing therapy or treatment.
No
The device is a Biomet® Tibial Locking Nail System, which is an intramedullary nail for fixing fractures and correcting deformities of long bones. Its stated intended use is for "alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis," which are all therapeutic and structural support functions, not diagnostic.
No
The device description clearly states it is an "intramedullary nail," which is a physical implantable hardware device, not software.
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 (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description: The Biomet® Tibial Locking Nail System is an implantable medical device designed to be surgically inserted inside the body (intramedullary) to fix fractures and deformities of the tibia.
- Intended Use: The intended use clearly describes a surgical procedure for alignment, stabilization, and fixation of bones, not a diagnostic test performed on a sample.
The information provided about the device's function, insertion method, and intended use all point to it being a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.
Product codes
HSB
Device Description
The Biomet® Tibial Locking Nail System is an intramedullary nail, designed to be inserted through the proximal tibia and proceed down the intramedullary canal of the tibia. The nail has both a proximal and distal bend to accommodate the anatomy of the tibia. Features include an internal locking/compression mechanism, a dynamization/locking slot, and numerous screw configurations to enable nail fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia, intramedullary canal of the tibia, long bones
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 2 7 2007
510(k) Summary
| Preparation Date: | November 28, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Trauma (aka EBI; names may be used interchangeably) |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Becky Earl/Debra L. Bing |
| Proprietary Name: | Biomet® Tibial Locking Nail System |
| Common Name: | Titanium intermedullary nails |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories (CFR 888.3020) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Intramedullary Rods-Various (Uniflex® Tibial Nail (Low Profile) - K982953 (Biomet Inc.)
Device Description:
The Biomet® Tibial Locking Nail System is an intramedullary nail, designed to be inserted through the proximal tibia and proceed down the intramedullary canal of the tibia. The nail has both a proximal and distal bend to accommodate the anatomy of the tibia. Features include an internal locking/compression mechanism, a dynamization/locking slot, and numerous screw configurations to enable nail fixation.
Intended Use:
The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.
Summary of Technologies:
The technological characteristics (materials, design, sizinq, aritculating surface, indications) of the Biomet® Tibial Locking Nail System are similar or identical to the predicate device.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. c/o Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581
1-13 9 7 2007
Re: K063570
Trade/Device Name: Biomet® Tibial Locking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 28, 2006 Received: November 29, 2006
Dear Ms. Earl:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Becky Earl
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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