(64 days)
K06395
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "temporary stabilization of bone segments or fragments until bone consolidation has been achieved", which is a therapeutic purpose.
No
Explanation: The device is intended for the temporary stabilization of bone segments or fragments following fractures, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable device (a flexible nail) and its intended use is for temporary stabilization of bone segments, which is a hardware function. There is no mention of any software component.
Based on the provided information, the Metaizeau™ Nailing System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Metaizeau™ Nailing System is a device intended for the temporary stabilization of bone segments or fragments within the body. It is a physical implant used in surgical procedures.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples or performing any diagnostic tests on bodily fluids or tissues.
Therefore, the Metaizeau™ Nailing System falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Metaizeau™ Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to:
- Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia . in children,
- Forearm fractures in children and young adolescents, and
- Fractures of the humerus in adults. .
Product codes
87 HSB
Device Description
The Metaizeau™ Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design. The nail is available in five diameters and two lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, Forearm, humerus
Indicated Patient Age Range
children, young adolescents, adults
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K06395
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
510(k) Summary of Safety and Effectiveness Metaizeau™ Nailing System
Proprietary Name: | Metaizeau™ Nailing System |
---|---|
Common Name: | Intramedullary Nail |
Classification Name/Reference: | Intramedullary Fixation Rod |
21 CFR §888.3020 | |
Device Product Code: | 87 HSB |
Proposed Regulatory Class: | Class II |
For Information contact: | Vivian Kelly, Senior Regulatory Affairs Specialist |
Howmedica Osteonics Corp. | |
325 Corporate Drive | |
Mahwah, NJ 07430 | |
Phone: (201) 831-5581 Fax: (201) 831-6038 | |
Date Summary Prepared: | October 20, 2006 |
DEC 27 2006 |
Description
The Metaizeau™ Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design. The nail is available in five diameters and two lengths.
Indications
The Metaizeau™ Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to: fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia in children, Forearm fractures in children and young adolescents, and fractures of the humerus in adults.
Substantial Equivalence:
The subject system is substantially equivalent to the predicate nailing system for the stabilization of long bone fractures using a closed technique. The supporting information included in following pages has sufficiently demonstrated the equivalence of the subject device to its predicates in regards to intended use, design, materials and operational principles.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Ms. Vivian Kelly Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K063225
Trade/Device Name: Metaizeau™ Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 20, 2006 Received: October 24, 2006
DEC 2 7 2006
Dear Ms. Kelly:
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. 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
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Page 2 - Ms. Vivian Kelly
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) 276-0210 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 other Ecturers, 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.
Barbara buchung
for
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: Metaizeau™ Nailing System
Indications for Use:
The Metaizeau™ Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to:
- Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia . in children,
- Forearm fractures in children and young adolescents, and �
- Fractures of the humerus in adults. .
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Staulaire buchno formsin
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KO6 395