(230 days)
Not Found
No
The document describes a purely mechanical medical device (intramedullary nails and accessories) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an intramedullary nail system used for the internal fixation of femoral fractures, nonunions, and malunions, which are conditions that require treatment for medical problems.
No
This device, SURESHOT™ TAN Nails, is an intramedullary nail system used for the internal fixation of femoral fractures. It is a therapeutic device designed to treat existing conditions rather than diagnose them.
No
The device description explicitly states it is comprised of intramedullary nails and accessories made of titanium, which are physical hardware components, 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 a device used for the surgical fixation of bone fractures in the femur. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as intramedullary nails and accessories (screws) made of titanium, designed to be implanted within the bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples.
Therefore, the SURESHOT™ TAN Nails are a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SURESHOT™ TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, SURESHOT™ TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
SURESHOT™ TAN Nails and Accessories are for single use only.
Product codes
JDS, HSB, HWC
Device Description
The subject devices are comprised of intramedullary nails and accessories such as lag screws, compression screws and set screws for use in the femur. All described components are manufactured from titanium material. The subject devices are available in the following size ranges:
| Device Type | Available Range of Diameters | Available Length Range |
|---|---|---|
| Nails | 9mm - 13mm | 32cm - 42cm |
| Lag Screws | 8.64mm (one diameter only) | 70mm - 125mm |
| Compression Screws | 6.22mm (one diameter only) | 30mm - 120mm |
| Set Screws | 6.6mm (one diameter only) | 25.4mm - 39.3mm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, femoral head
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)
To further support a determination of substantial equivalence, various types of pre-clinical testing were conducted on the subject devices in comparison against one or more of the previously cleared predicate devices described above. The types of pre-clinical testing included: finite element analysis, construct fatigue testing of a nail construct with appropriate accessory devices and axial pullout testing of the lag screw from appropriate test media.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981529, K040212, K040462, K061019, K050226, K010801
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 SURESHOT™ TAN Nails and Accessories
| Submitted By: | Smith & Nephew, Inc.
Orthopaedics
1450 Brooks Road
Memphis, TN 38116 | APR 8 3 2010 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------|--------------|
| Date: | September 4, 2009 | |
| Contact Person: | David Henley, Regulatory Affairs Project Manager
Tel: (901) 399-6487 Fax: (901) 398-5146 | |
| Proprietary Name: | SURESHOT™ TAN Nails and Accessories | |
| Common Name: | Intramedullary Nails and Accessories | |
| Classification Name and Reference: | 21 CFR 888.3030, Single/multiple component metall
bone fixation appliances and accessories - Class II | |
| Device Product Code and Panel Code: | JDS / Orthopedics / 87 | |
Device Description:
The subject devices are comprised of intramedullary nails and accessories such as lag screws, compression screws and set screws for use in the femur. All described components are manufactured from titanium material. The subject devices are available in the following size ranges:
| Device Type | Available Range of Diameters | Available Length Range |
|---|---|---|
| Nails | 9mm - 13mm | 32cm - 42cm |
| Lag Screws | 8.64mm (one diameter only) | 70mm - 125mm |
| Compression Screws | 6.22mm (one diameter only) | 30mm - 120mm |
| Set Screws | 6.6mm (one diameter only) | 25.4mm - 39.3mm |
Intended Use:
SURESHOT™ TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, SURESHOT™ TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
Technological Characteristics:
Components comprising SURESHOT™ TAN Nails and Accessories are very similar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological design characteristics.
p. 1 of 2
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Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.
- Titanium Nail System (TriGen™ Titanium Intramedullary Nail System) K981529
- · TriGen™ InterTAN Nail K040212
- · TriGen™ · Trochanteric Antegrade Nail K040462
- · TriGen™ Meta-Nails Retrograde Femoral and Tibia Nails K061019
- · Asian Intramedullary Hip Screw (IMHS) K050226
- · T2 Femoral Nail (Stryker/Howmedica/Osteonics Corp.) K010801
To further support a determination of substantial equivalence, various types of pre-clinical testing were conducted on the subject devices in comparison against one or more of the previously cleared predicate devices described above. The types of pre-clinical testing included: finite element analysis, construct fatigue testing of a nail construct with appropriate accessory devices and axial pullout testing of the lag screw from appropriate test media.
p. 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, and a small, curved line that forms the head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 3 2010
Smith and Nephew Inc. % Mr. David Henley Regulatory Affairs Project Manger 1450 Brooks Road Memphis, Tennessee 38116
Re: K092748
Trade/Device Name: SURESHOT™ TAN Nails and Accessories Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB, HWC Dated: February 24, 2010 Received: February 25, 2010
Dear Mr. Henley:
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. 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.
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
· ·
3
Page 2 - Mr. David Henley
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFl)A/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Chubur Budup
Mark N. Melkers VDirector Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
K092748 510(k) Number (if known): __
Device Name: SURESHOT™ TAN Nails and Accessories
Indications for Use:
SURESHOT™ TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; bono naotaroo, covery connytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; imponding patifores; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, SURESHOT™ TAN Nails contain holes/slots proximally to accept screws that in addition, OOT(2017) head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
SURESHOT™ TAN Nails and Accessories are for single use only.
AND/OR Over-the-Counter Use Prescription Use XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX (Part 21 CFR 807 Subpart C) (Part 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)
Onetu for mxn
(Division Sign 20)
Division Sign-Q Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K092748