(203 days)
Not Found
No
The device description and performance studies focus on the mechanical components and bench testing of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes.
The device is an implantable intramedullary nail system for the fixation of bone fractures, which is a therapeutic purpose.
No
Explanation: The device is an implantable medical device (trochanteric nail) used for the fixation of fractures, not for diagnosing medical conditions. Its function is therapeutic and structural.
No
The device description explicitly details multiple hardware components made of titanium alloy and stainless steel, including intramedullary rods, screws, caps, and instruments. There is no mention of software as a component of the device itself.
Based on the provided information, the Dyna Locking Trochanteric Nail™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures." This describes a surgical implant used to treat bone fractures.
- Device Description: The description details the physical components of the implant (rods, screws, caps) and the material it's made from (titanium alloy). This is consistent with a medical device used for internal fixation.
- 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 screening. IVD devices typically involve reagents, analyzers, or test kits.
Therefore, the Dyna Locking Trochanteric Nail™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Subtrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures
- Segmental fractures .
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
Product codes (comma separated list FDA assigned to the subject device)
HSB, HTY
Device Description
The Dyna Locking Trochanteric Nail™ consists of intramedullary rod, neck screw assembly(neck screw + wedge wing), locking screw, fixed nail cap, slidable nail cap, end cap, and short end cap. The rods are available in a variety of diameters and lengths and have holes located at the proximal and distal ends for passing of neck .screw and for fixation to bone by means of locking screws, respectively. The neck screws are inserted into the proximal hole of rod angle with 120, 125, 130, 135 degrees, selectively. The wedge wing in the neck screw prevents the twisting of the neck screw in the femoral head. The fixed & slidable nail cap are fixed in the rod to prevent operation failure due to the excessive motion of neck screw. The fixed nail cap prevents the rotation and movement of neck screw, but slidable nail cap is applicable only for rotation. Meanwhile, the end cap (or short end cap) screws into the threaded end of the nails to prevent bone ingrowth, otherwise newbone in the nail hamper to remove the nail. The end cap is used primarily, however short end cap which do not protruding out of nail also may be used according to patients' conditions. All implants of Dyna Locking Trochanteric Nail " are single use device, supplied non-sterile and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Trochanteric Nail™
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intramedullary canal and head of femur
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)
The Dyna Looking Trochanteric Nail™ was tested in a non clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Dyna Locking Trochanteric Nail™ is substantially equivalent to the predicate devices.
The following tests were performed:
- 4-point bend test of rods ●
- Tosional test of rods .
- 3-point bend test of locking screws .
- Cutout test of neck screws ●
- Dynamic compression test of full constructs .
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.
K860756, K981529, K081152, K973240, K953607
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
K093707 (1/3)
JUN 2 3 2018
5. 510(k) Summary
| Manufacturer: | U & I Corporation
529-1, Yonghyun-dong, Uijungbu
Kyunggi-Do, Korea 480-050
Gyeong-Je Kwon, Regulatory Affairs Specialist |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
529-1, Yonghyun-dong, Uijungbu
Kyunggi-Do, Korea 480-050 |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist |
| Date Prepared: | June 21, 2010 |
| Device Name: | Trade Name: Dyna Locking Trochanteric Nail™ |
| Common Name: | Intramedullary Fixation System |
| Classification Name: | Intramedullary Fixation Rod (HSB), per 21 CFR 888.3020 |
| Product Code: | HSB |
| Predicate Devices: | Grosse and Kempf Locking Nail System (K860756)
Delta II Femoral Nail (K981529)
T2 Femoral Nail (K081152)
Proximal Femoral Nail System (K973240)
Dynamic Hip Screw (K953607) |
Description of Device:
The Dyna Locking Trochanteric Nail™ consists of intramedullary rod, neck screw assembly(neck screw + wedge wing), locking screw, fixed nail cap, slidable nail cap, end cap, and short end cap. The rods are available in a variety of diameters and lengths and have holes located at the proximal and distal ends for passing of neck .screw and for fixation to bone by means of locking screws, respectively. The neck screws are inserted into the proximal hole of rod angle with 120, 125, 130, 135 degrees, selectively. The wedge wing in the neck screw prevents the twisting of the neck screw in the femoral head. The fixed & slidable nail cap are fixed in the rod to prevent operation failure due to the excessive motion of neck screw. The fixed nail cap prevents the rotation and movement of neck screw, but slidable nail cap is applicable only for rotation. Meanwhile, the end cap (or short end cap) screws into the threaded end of the nails to prevent bone ingrowth, otherwise newbone in the nail hamper to remove the nail. The end cap is used
Dyna Locking Trochanteric Nail™
Image /page/0/Picture/6 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a bold, stylized font, with the "&" symbol connecting the two letters. To the right of "U&I", the word "CORPORATION" is written in a smaller, sans-serif font. The overall design is simple and professional, with a focus on the company's name.
1
primarily, however short end cap which do not protruding out of nail also may be used according to patients' conditions.
All implants of Dyna Locking Trochanteric Nail " are single use device, supplied non-sterile and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Trochanteric Nail™
Intended Use:
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Subtrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures .
- Segmental fractures
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
Substantial Equivalence:
The Dyna Locking Trochanteric Naill is substantially equivalent to Grosse and Kempf Locking Nail System (K860756). Delta II Femoral Nail (K981529). T2 Femoral Nail (K081152). Proximal Femoral Nail System (K973240), Dynamic Hip Screw (K953607) in design, performance, function and intended use.
1. Comparison technological characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities:
- The similar indications for use .
- Similar design features ●
- Incorporate the same or similar materials (Ti-allov based biocompatible materials) .
- The equivalent mechanical performance .
2. Performance Testing
The Dyna Looking Trochanteric Nail™ was tested in a non clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. The testing met all
Dyna Locking Trochanteric Nail™
U&I CORPORATION
Page 10 of 52
2
K093707(3/3)
acceptance criteria and verifies that performance of the Dyna Locking Trochanteric Nail™ is substantially equivalent to the predicate devices.
The following tests were performed:
- 4-point bend test of rods ●
- Tosional test of rods .
- 3-point bend test of locking screws .
- Cutout test of neck screws ●
- Dynamic compression test of full constructs .
3. Conclusion
The data and information provided in this submission support the conclusion that the Dyna
Locking Trochanteric Nail™ is substantially equivalent to its predicate devices with indications for use and technological characteristics.
Dyna Locking Trochanteric Nail™
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
U&I Corporation % Gyeong-Je Kwon Regulatory Affairs Specialist 529-1 Yonghyun-dong, Uijungbu Kyunggi-do 480-050 Republic of Korea
JUN 2 3 2010
Re: K093707
Trade/Device Name: Dyna Locking Trochanteric Nail™ Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB, HTY Dated: May 24, 2009 Received: May 26, 2009
Dear Gyeong-Je Kwon:
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
4
Page 2 - Gyeong-Je Kwon
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 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/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/ReportaProblem/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: Dyna Locking Trochanteric Nail™
Indications for Use:
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Subtrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures
- Segmental fractures .
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\frac{\text{Jouted}}{\text{(Division Sign) for mxn}}$
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093707
Dyna Locking Trochanteric Nail™
U&i CORPORATION