(90 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a "Modular Arthrodesis Nail," is used for the "replacement of segmental defects of long bone" and "arthrodesis of the knee" in various medical conditions, indicating its direct role in treating and managing health conditions, which aligns with the definition of a therapeutic device.
No
The device is a Modular Arthrodesis Nail intended for skeletal fixation (arthrodesis of the knee), which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines physical components made of titanium alloy, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a "Modular Arthrodesis Nail," a multi-component device designed to provide "arthrodesis fixation of the knee." This is a surgical implant used within the body.
- Intended Use: The intended use is for the "replacement of segmental defects of long bone" and "arthrodesis of the knee," which are surgical procedures.
- Anatomical Site: The anatomical site is the "Knee, long bone," which are parts of the body where surgical implants are placed.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Indications include:
- Treatment of patients who are not candidates for total knee arthroplasty l .
- Irretrievably failed total knee arthroplasty 2.
- Limb salvage in oncology surgery 3.
- Trauma 4.
- Any other condition where there is little soft tissue or bony tissue available for 5. support, and arthrodesis is the treatment of choice.
These devices are intended for cemented use only.
Product codes
HSB
Device Description
The Modular Arthrodesis Nail is a multi-component device designed to provide arthrodesis fixation of the knee. The device has a central locking collar that connects fernoral and tibial adapter segments. The adapter segments are available in two resection lengths (1 cm or 3 cm), each with two body styles (standard or elliptical). All components of the Modular Arthrodesis Nail are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee; long bone
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
Mechanical testing indicated that the Modular Arthrodesis Nails are substantially equivalent to the predicate devices for the uses indicated. Clinical testing was not required for these components to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K993603, K982953, K020384, K002757
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
042409 :12
DEC - 2 2004
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are all capitalized and outlined in black, with the interior of the letters being white. The "O" in the middle is a perfect circle, and the "E" and "T" have a unique, geometric design.
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267-6639 ext. 1568
FAX: (574) 372-1683 |
| Proprietary Name: | Modular Arthrodesis Nail |
| Common Name: | Titanium Intramedullary Rod |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories (21 CFR §888.302) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Wichita® Fusion Nail - Howmedica Inc. (K993603) Titanium Intramedullary Nails - Biomet Inc. (K982953) T2 Arthrodesis Nail System - Howmedica Inc. (K020384) Orthopedic Salvage System - Biomet Inc. (K002757)
Device Description:
The Modular Arthrodesis Nail is a multi-component device designed to provide arthrodesis fixation of the knee. The device has a central locking collar that connects fernoral and tibial adapter segments. The adapter segments are available in two resection lengths (1 cm or 3 cm), each with two body styles (standard or elliptical). All components of the Modular Arthrodesis Nail are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F-136.
Intended Use:
The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knce.
Indications include:
-
- Treatment of patients who are not candidates for total knee arthroplasty.
- Irretrievably failed total knee arthroplasty 2.
-
- Limb salvage in oncology surgery,
MAILING ADDRESS PO. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E. Bell Drive W:nisaw, IN 46582
대
OFFICE 574.267.6639
FAX 574.267.81.37
82
E MAIL biomet@bionet.com
1
-
- Trauma
-
- Any other condition where there is little soft tissue or bony tissue available for support, and arthrodesis is the treatment of choice.
These devices are intended for cemented use only.
Summary of Technologies: The Modular Arthrodesis Nail has the same intended use (arthrodesis), the same functional characteristics (rigid fixation) as the predicate devices, and is made of the same titanium alloy material as the predicate Titanium Intramedullary Nails and Orthopedic Salvage System (OSS) components used with the Modular Arthrodesis Nail.
Non-Clinical Testing: Mechanical testing indicated that the Modular Arthrodesis Nails are substantially equivalent to the predicate devices for the uses indicated.
Clinical Testing: Clinical testing was not required for these components to support substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2004
Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell DR. P.O. Box 587 Warsaw, IN 46581
Re: K042409
Trade/Device Name: Modular Arthrodesis Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 2, 2004 Received: September 3, 2004
Dear Mr. Baker:
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 docs 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.
3
Page 2 - Mr. Gary Baker
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Statement of Indications For Use
510(k) Number (IF KNOWN): Koy2489
Device Name: Modular Arthrodesis Nail
Indications for Use:
The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Indications include:
- Treatment of patients who are not candidates for total knee arthroplasty l .
- Irretrievably failed total knee arthroplasty 2.
- Limb salvage in oncology surgery 3.
- Trauma 4.
- Any other condition where there is little soft tissue or bony tissue available for 5. support, and arthrodesis is the treatment of choice.
These devices are intended for cemented use only.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evanuation (ODE)
lellin Wht
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number C042405