(43 days)
Not Found
No
The 510(k) summary describes a mechanical implant (nail, screws, blades) for fracture fixation and does not mention any software, image processing, AI, or ML capabilities. The performance studies focus on mechanical equivalence to predicate devices.
Yes
The Magnum Nail is intended for fixation of fractures and bone reconstruction, which are therapeutic interventions.
No
The document describes a medical device (Magnum Nail) used for the fixation of bone fractures, osteotomy, and reconstruction, which are all treatment procedures. It does not mention any function related to identifying, analyzing, or determining a medical condition.
No
The device description explicitly states it consists of physical components like nails, screws, and blades, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of stable and unstable fractures of the proximal femur." This is a surgical implant used in vivo (within the body) to stabilize bone fractures.
- Device Description: The description details components like nails, screws, and blades, which are all physical implants used in orthopedic surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a surgical implant for bone fixation, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
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.
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
NOV 1 8 2009
| NOV 18 2009 | |
|---|---|
| 8. 510(k) Summary | |
| Sponsor: | Robert Reid Inc. |
| 4-22-2, Koishikawa, Bunkyo-ku | |
| Tokyo 112-0002 Japan | |
| Phone +81-3-3830-7375 | |
| Fax +81-3-3830-7376 | |
| Contact Person: | Teiji Nakamura, Marketing Director |
| Proposed Trade Name: | Magnum Nail |
| Device Classification | Class II |
| Classification Name: | Rod, fixation, intramedullary and accessories |
| Regulation: | 888.3020 |
| Device Product Code: | HSB |
| Device Description: | The Magnum Nail consists of nails, distal bone screws, cannulated lag |
| screws, cannulated blades and set screws in a variety of sizes to | |
| accommodate differing anatomic requirements. | |
| Intended Use: | The Magnum Nail is intended for use in fixation of stable and unstable |
| fractures of the proximal femur. The types of proximal femoral fractures | |
| include pertrochanteric, intertrochanteric, basal neck fractures, high | |
| subtrochanteric fractures and combinations of these fractures. The Magnum | |
| Nail is also indicated for use in osteotomy, nonunions and malunions, bone | |
| reconstruction following tumor resection, grafting and pathological | |
| fractures and revision procedures. | |
| Materials: | The Magnum Nail components are manufactured from titanium alloy (Ti- |
| 6Al-4V) as described by ASTM F136. | |
| Substantial | |
| Equivalence: | Documentation was provided which demonstrated the Magnum Nail to be |
| substantially equivalent to previously cleared devices (Fixion™ | |
| Interlocking Proximal Femoral Nailing System, K010988 and Trochanteric | |
| Fixation Nail System, K011857). The substantial equivalence is based upon | |
| equivalence in basic design, intended use, indications, anatomic sites and | |
| mechanical performance. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem that resembles a caduceus, a symbol often associated with medicine and healthcare. The emblem is composed of a series of curved lines that form a wing-like shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 1 3 2009
Robert Reid Inc. % Karen E. Warden, Ph. D. Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141
Re: K093089
Trade/Device Name: Magnum Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 28, 2009 Received: October 1, 2009
Dear Dr. Warden:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Karen E. Warden, Ph.D.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Sincerely yours,
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Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
7. Indications for Use Statement
510(k) Number: K. 093080
Device Name: Magnum Nail
Indications for Use:
The Magnum Nail is intended for use in fixation of stable fractures of the proximal femur. The types of proximal fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
Prescription Use X Over-the-Counter Use AND/OR (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danuta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. K093089
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