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

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™

AI/ML Overview

This document describes the Dyna Locking Trochanteric Nail™, an intramedullary fixation system. The testing described is non-clinical (bench testing) to establish substantial equivalence to predicate devices, not a study involving human subjects or AI algorithms. As such, many of the requested categories are not applicable to this submission.

Here's the breakdown of the information provided in the context of your request:

Acceptance Criteria and Device Performance

The submission states that the "testing met all acceptance criteria and verifies that performance of the Dyna Locking Trochanteric Nail™ is substantially equivalent to the predicate devices." However, it does not explicitly list the specific numerical acceptance criteria for each test. Instead, it implies successful comparison to the predicate devices.

Test Performed	Acceptance Criteria (Stated)	Reported Device Performance (Stated)
4-point bend test of rods	Not explicitly stated (implied: performance substantially equivalent to predicate devices)	Met all acceptance criteria (implied: substantially equivalent to predicate devices)
Torsional test of rods	Not explicitly stated (implied: performance substantially equivalent to predicate devices)	Met all acceptance criteria (implied: substantially equivalent to predicate devices)
3-point bend test of locking screws	Not explicitly stated (implied: performance substantially equivalent to predicate devices)	Met all acceptance criteria (implied: substantially equivalent to predicate devices)
Cutout test of neck screws	Not explicitly stated (implied: performance substantially equivalent to predicate devices)	Met all acceptance criteria (implied: substantially equivalent to predicate devices)
Dynamic compression test of full constructs	Not explicitly stated (implied: performance substantially equivalent to predicate devices)	Met all acceptance criteria (implied: substantially equivalent to predicate devices)

Study Details (Not applicable for this type of device and submission)

Given that this is a 510(k) premarket notification for a medical implant and the study described is non-clinical bench testing, many of the requested details about human-in-the-loop performance, AI, and ground truth for clinical data are not present.

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing. The document does not specify the number of devices tested for each bench test. Data provenance (country of origin, retrospective/prospective) is not relevant to non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for clinical or AI studies (e.g., expert consensus on images or pathology results) is not relevant to mechanical bench testing. The "ground truth" for these tests would be the established engineering standards or the performance of predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This submission is for a physical medical device, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical AI performance. For bench testing, the "ground truth" is defined by established engineering principles and performance of predicate devices.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

K093707 (1/3)

JUN 2 3 2018

5. 510(k) Summary

Manufacturer:	U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050Gyeong-Je Kwon, Regulatory Affairs Specialist
Sponsor:	U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-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:

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:

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,

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:

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

Regulation Number and Section

§ 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.