(45 days)
Not Found
No
The summary describes a mechanical implant (intramedullary nail) and its features, with no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies are non-clinical mechanical tests.
Yes
The device is used for the "fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis," which describes therapeutic purposes.
No
This device is an implantable intramedullary nail system used for the fixation and stabilization of bone fractures and deformities, not for diagnosing medical conditions.
No
The device description clearly states it is a "set of intramedullary nails," which are physical implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are "to be implanted into the femur for alignment, stabilization and fixation of fractures... and for arthrodesis." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description confirms it's a "set of intramedullary nails," which are also implanted devices.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided consistently points to this being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
These devices are to be implanted into the femur for alignment, stabilization, fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Biomet® Femoral Locking Nail System is a set of intramedullary nails, designed for both antegrade and retrograde applications. Features include an internal locking/compression mechanism 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
femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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): 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.
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
SEP 2 0 2007
510(k) Summary
| Preparation Date: | August 3, 2007 |
|---|---|
| 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® Femoral Locking Nail System |
| Common Name: | Titanium intramedullary nails |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories (CFR 888.3020) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K983641, Holland Nail™ Ecgany Flamet); K982953, Uniflex® Nailing System (Biomet); and K023267, T2™ Supracondylar Nailing System (Howmedica/Stryker)
Device Description:
The Biomet® Femoral Locking Nail System is a set of intramedullary nails, designed for both antegrade and retrograde applications. Features include an internal locking/compression mechanism and numerous screw configurations to enable nail fixation.
Intended Use:
The Biomet® Femoral Locking Nail is intended to be used as follows:
These devices are to be implanted into the femur for alignment, stabilization, fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.
Summary of Technologies:
Summary of Technological characteristics (materials, design, sizing, aritculating surface, indications) of the Biomet® Femoral Locking Nail System are similar or identical to the predicate devices.
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., except for the T2™ Supracondylar Nailing System which belongs to Howmedica/Styker
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three stripes forming its body and wing, and it faces to the right. The seal is in black and white.
SEP 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Becky Earl P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K072161
Trade/Device Name: Biomet® Femoral Locking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 3, 2007 Received: August 6, 2007
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
ChavargBucelund
Mark N. Melkerso 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):_ K 0 7 2 1 6 l
Device Name: Biomet® Femoral Locking Nail System
Indications For Use: These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for 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)
Barbara Buehr
vision Sigr Division of General, Restorative, and Neurological Devices
510(k) Number. K072161
Page 1 of 1