(446 days)
Not Found
No
The device description and intended use are purely mechanical, describing an intramedullary nailing system for fracture fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is an intramedullary nailing system used for stabilizing and fixing femoral fractures, which are structural repairs rather than therapeutic treatments.
No
The device is an intramedullary nailing system intended for the fixation of femoral fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components made of titanium, such as nails, screws, and a closure cap, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (intramedullary nail system) used to stabilize bone fractures in the femur. This is a physical intervention on the body, not a test performed on a specimen outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical components or processes associated with IVDs, such as reagents, assays, specimen collection, or analysis of biological samples.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the form. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
Product codes
HSB
Device Description
The Elos Intramedullary Nailing System consists of a titanium nail, cephalic screw, diaphyseal screw, optional closure cap, and a pre-assembled cannulated grub screw to lock cephalic screws. The short nails are available in lengths of 180mm and 10mm and 11mm in diameter. The short nails also have CCD angles of 122° and 127°. The 180mm short nail is available in one configuration for both left and right femurs and the 240mm nail is available in both left and right configurations. The long length nails are 11mm in diameter, in lengths of 300mm, 340mm, 380mm, 400mm, 420m, 440mm and 460 mm and are offered in left and right configurations. The long nails are also offered with CCD angles of 122° and 127°. The nails, screws, and closure cap undergo an anodic oxidation (Type II Anodization) treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur (intertrochanteric fractures, femoral neck, subtrochanteric fractures, femoral shaft)
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
The Elos® Intramedullary Nailing System has been evaluated through non-clinical performance testing for mechanical fatigue. The testing demonstrated that the Elos® Intramedullary Nailing System components met performance requirements and are as safe and effective as their predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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
July 19, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.
Intrauma S.p.A. Via Genova, 19 Rivoli (TO) Italy 10098
Hollace Saas Rhodes Vice President, Orthopedic Regulatory Affairs MCRA LLC 1050 K Street NW Washington DC 20001
Re: K201147
Trade/Device Name: Elos® Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: June 17, 2021 Received: June 17, 2021
Dear Hollace Saas Rhodes,
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm = identifies = combination = product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorywebsite the DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K201147
Device Name
Elos® Intramedullary Nailing System
Indications for Use (Describe)
The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the form. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image contains the word "intrauma" in gray pixelated letters. To the left of the word is a blue pixelated image that resembles a gear or flower. The image is simple and appears to be a logo or brand name.
510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the Intrauma S.p.A. 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Sponsor: | Piero Costa
Intrauma S.p.A.
Via Genova, 19
Rivoli (TO) Italy 10098 | | | |
|----------------------|--------------------------------------------------------------------------------------------------|---------------|---------|-------|
| Contact: | Hollace Saas Rhodes
MCRA, LLC
1050 K Street, NW
Washington DC 20001
Ph: 202-552-5800 | | | |
| Date Prepared: | July 16, 2021 | | | |
| Proposed Class: | II | | | |
| Proprietary Name: | Elos® Intramedullary Nailing
System | | | |
| Common Name: | Intramedullary Fixation Rod | | | |
| Classification Name: | Intramedullary Fixation Rod | | | |
| Regulation Number: | 21 CFR 888.3020 | | | |
| Product Codes: | HSB | | | |
| Predicate Device(s): | | | | |
| Manufacturer | Device Name | 510(k) Number | Procode | Class |
| Gamma3™ Nail System | Stryker
(Howmedica Osteonics Corp) | K032244 | HSB | II |
| Gamma3™ Nail System | Stryker
(Howmedica Osteonics Corp) | K034002 | HSB | II |
Indication for Use
The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the femur. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, pathological fractures, and impending pathological fractures.
4
Image /page/4/Picture/1 description: The image shows the logo for "Intrauma". The logo consists of a blue, gear-shaped icon on the left, followed by the word "intrauma" in gray, lowercase letters. The logo appears to be for a company or organization named Intrauma.
Device Description
The Elos Intramedullary Nailing System consists of a titanium nail, cephalic screw, diaphyseal screw, optional closure cap, and a pre-assembled cannulated grub screw to lock cephalic screws. The short nails are available in lengths of 180mm and 10mm and 11mm in diameter. The short nails also have CCD angles of 122° and 127°. The 180mm short nail is available in one configuration for both left and right femurs and the 240mm nail is available in both left and right configurations. The long length nails are 11mm in diameter, in lengths of 300mm, 340mm, 380mm, 400mm, 420m, 440mm and 460 mm and are offered in left and right configurations. The long nails are also offered with CCD angles of 122° and 127°. The nails, screws, and closure cap undergo an anodic oxidation (Type II Anodization) treatment.
Performance Data
The Elos® Intramedullary Nailing System has been evaluated through non-clinical performance testing for mechanical fatigue. The testing demonstrated that the Elos® Intramedullary Nailing System components met performance requirements and are as safe and effective as their predicate devices.
Comparison of Technological Characteristics
The Elos® Intramedullary Nailing System has the same indications for use, materials, and similar design features as compared with the predicate systems. The bench testing demonstrates that the performance characteristics of the Elos® Intramedullary Nailing System are equivalent to those of other legally marketed intramedullary nail systems, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
Substantial Equivalence
The subject device was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, function and performance.
Conclusion
The Elos Intramedullary Nailing System is substantially equivalent to the cited predicate device with respect to indications for use, design, function, and performance.