(66 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is an intramedullary nail used for the fixation of fractures in the femur and tibia, which is a therapeutic purpose.
No
The device is an intramedullary nail intended for the fixation of fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the device is manufactured from titanium alloy and is intended for insertion into the medullary canal, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an intramedullary nail for the fixation of bone fractures in the femur and tibia. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description confirms it's a physical implant made of titanium alloy for insertion into the medullary canal.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Sirus intramedullary nail for femur with cap screw and corresponding locking screws:
• All compound and simple femoral shaft fractures
• Sub-trochanteric fractures
• Pseudarthrosis and delayed union
Sirus intramedullary nail for femur in combination with the Sirus cervical screws:
• Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures
Sirus intramedullary nail for tibia with cap screw and corresponding locking screws:
• Simple, compound first- and second-degree tibial shaft fractures
• Pseudarthrosis and delayed union
Product codes
HSB
Device Description
The Sirus Intramedullary Nails are manufactured from titanium alloy, and are available in a variety of lengths and diameters. They are intended for insertion into the medullary canal of the femur or tibia for the fixation of fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia
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 Performance and Conclusions: The results of non-clinical analysis demonstrate that the device is safe and effective and substantially equivalent to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K932330, K040336, K982601, K010801, K014220, K021744
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
093270
y
Image /page/0/Picture/1 description: The image shows the letters 'f' and 'z' in a handwritten style. The letters are connected, with the 'f' appearing first and the 'z' following it. The handwriting is simple and clear, making the letters easily recognizable.
Image /page/0/Picture/2 description: The image contains the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a bold, sans-serif font. The letter "Z" is black, while the circle is white with a black outline, and the word "zimmer" is also black.
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC
Manager, Regulatory Affairs
Telephone: (574) 372-4523
Fax: (574) 372-4605 |
| Date: | November 24, 2004 |
| Trade Name: | Sirus ® Intramedullary Nail |
| Classification Name
and Reference: | Intramedullary Fixation Rod
21 CFR § 888.3020 |
| Predicate Devices: | Unreamed Tibial Nail, manufactured by Synthes,
K932330, cleared 03/08/1996
Lateral Entry Femoral Nail System by Synthes,
K040336, cleared 04/12/2004
Osteo IC Retrograde/Antegrade Femoral Nail,
manufactured by Osteonics, K982601, cleared
09/14/1998
T2 Femoral Nail System, manufactured by
Howmedica Osteonics, K010801, K014220, and
K021744; cleared 04/06/2001, 01/25/2002, and
06/26/2002, respectively |
| Device Description: | The Sirus Intramedullary Nails are manufactured
from titanium alloy, and are available in a variety of
lengths and diameters. They are intended for
insertion into the medullary canal of the femur or
tibia for the fixation of fractures. |
1
Image /page/1/Picture/1 description: The image contains the word "zimmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized "Z" inside. The logo and the word "zimmer" appear to be part of a company or brand identity.
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જુજરી, ચણ
| Intended Use: | Sirus intramedullary nail for femur with cap
screw and corresponding locking screws: |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • All compound and simple femoral shaft fractures |
| | • Sub-trochanteric fractures |
| | • Pseudarthrosis and delayed union |
| | Sirus intramedullary nail for femur in
combination with the Sirus cervical screws: |
| | • Shaft fractures in combination with femoral neck
fractures or peritrochanteric fractures |
| | Sirus intramedullary nail for tibia with cap
screw and corresponding locking screws: |
| | • Simple, compound first- and second-degree tibial
shaft fractures |
| | • Pseudarthrosis and delayed union |
| Comparison to Predicate Device: | The Sirus Intramedullary Nail has the same
intended use, has similar performance
characteristics, is manufactured from similar
materials using similar processes, and is similar in
design to the predicate devices. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | The results of non-clinical analysis demonstrate that
the device is safe and effective and substantially
equivalent to the predicate device(s). |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and converge, resembling a human figure or a stylized representation of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Zimmer GMBH C/o Zimmer, Inc Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 465810
Re: K043270
Trade/Device Name: Sirus™ Intramedullary Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 24, 2004 Received: November 26, 2004
Dear Ms. Williams:
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.
Picase 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 fisting (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 - Ms. Laura D. Williams, RAC
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 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/industry/support/index.html.
Sincerely yours,
A. Mark A. Millkens
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
K64 3270 141
Indications for Use
510(k) Number (if known):
Device Name:
Sirus™ Intramedullary Nail
Indications for Use:
Sirus intramedullary nail for femur with cap screw and corresponding locking screws
- · All compound and simple femoral shaft fractures
- · Sub-trochanteric fractures
- · Pseudarthrosis and delayed union
Sirus intramedullary nail for femur in combination with the Sirus cervical screws
- · Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures
Sirus intramedullary nail for tibia with cap screw and corresponding locking screws
- · Simple, compound first- and second-degree tibial shaft fractures
- · Pseudarthrosis and delayed union
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
Division of General, Resative,
and Neurological Devices
$10(k) Number
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