DYNA LOCKING ANKLE NAIL

K120419 · U&I Corp. · HSB · May 21, 2012 · Orthopedic

Device Facts

• Record ID: K120419
• Device Name: DYNA LOCKING ANKLE NAIL
• Applicant: U&I Corp.
• Product Code: HSB · Orthopedic
• Decision Date: May 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dyna Locking Ankle Nail™ is used in various indications as follows. - Post-traumatic and degenerative arthritis involving both ankle and subtalar joints - Rheumatoid arthritis - Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body - Revision of failed total ankle arthroplasty with subtalar intrusion - Talar deficiency conditions requiring tibiocalcaneal arthrodesis - Avascular necrosis of the talus - Neuroarthropathy or neuropathic ankle deformity - Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease - Severe pilon fractures with trauma to the subtalar joint

Device Story

Dyna Locking Ankle Nail™ is an intramedullary fixation system consisting of a nail, locking screw, set screw, and end cap. Used by orthopedic surgeons in clinical settings to achieve tibiocalcaneal arthrodesis. The device provides mechanical stabilization of the ankle and subtalar joints. Components are manufactured from titanium alloy (Ti-6Al-4V ELI). The system is supplied non-sterile for single use. Surgeons implant the device to facilitate bone fusion in patients with severe joint degeneration, deformity, or trauma. The end cap prevents bone ingrowth into the nail. Clinical benefit is derived from the stabilization of the joint complex, allowing for fusion and correction of deformity.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included static 4-point bend and torsion tests, and dynamic 4-point bend testing to verify mechanical performance against predicate devices.

Technological Characteristics

Intramedullary fixation rod. Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM 136. Components: Nail, locking screw, set screw, end cap. Supplied non-sterile. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring ankle/subtalar arthrodesis due to post-traumatic/degenerative arthritis, rheumatoid arthritis, failed prior arthrodesis or arthroplasty, talar deficiency, avascular necrosis, neuroarthropathy, severe deformity (e.g., talipes equinovarus, paralysis), or severe pilon fractures with subtalar trauma.

Regulatory Classification

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.

Predicate Devices

• Grosse & Kempf Locking Nail System (K860756)
• T2 Ankle Arthrodesis Nail (K051590)
• Titanium Ankle Arthrodesis Nail (K021786)

Submission Summary (Full Text)

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K120419(1/3)

MAY 2 1 2012

# 5. 510(k) Summary

| Manufacturer: | U & I Corporation<br>529-1, Yonghyun-dong, Uijungbu<br>Kyunggi-Do, Korea 480-050 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation<br>529-1, Yonghyun-dong, Uijungbu<br>Kyunggi-Do, Korea 480-050 |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist |
| Date Prepared: | February 6, 2012 |
| Device Name: | Trade Name: Dyna Locking Ankle NailTM |
| Common Name: | Intramedullary Fixation System |
| Classification Name: | Intramedullary Fixation Rod (HSB), per 21 CFR 888.3020 |
| Product Code: | HSB |
| Predicate Devices: | Grosse & Kempf Locking Nail System (K860756)<br>T2 Ankle Arthrodesis Nail (K051590)<br>Titanium Ankle Arthrodesis Nail (K021786) |

## Description of Device:

The Dyna Locking Ankle Nail™ consists of Ankle Nail, Locking Screw, Set Screw, and End Cap. The Ankle nails are available in variety of diameters and lengths. And End Cap screws into the threaded end of the nail to prevent bone ingrowth. Locking Screw has the self-tap at the end of the screw.

All components of the Dyna Locking Ankle Nail™ are single use device, supplied non-sterile, and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM 136. Specialized instruments made from surgical instrument grade stainless steel are available for the instrumentation and removal of the Dyna Locking Ankle Nail™.

Dyna Locking Ankle Nail™

**CORPORATION**

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K120419(2/3)

#### Intended Use:

The Dyna Locking Ankle Nail™ is used in various indications as follows.

- Post-traumatic and degenerative arthritis involving both ankle and subtalar ● joints
- Rheumatoid arthritis ●
- Revision of failed ankle arthrodesis with subtalar involvement of with an . insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion
- Talar deficiency conditions requiring tibiocalcaneal arthrodesis
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint ●

#### Substantial Equivalence:

The Dyna Locking Ankle Nail™ is substantially equivalent to Grosse and Kempf Locking Nail System (K860756), T2 Ankle Arthrodesis Nail (K051590), Titanium Ankle Arthrodesis Nail (K021786) 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 similaritiesL\:

- . The similar indications for use
- Similar design features
- Incorporate the same or similar materials
- The equivalent mechanical performance

2. Performance Testing

The Dyna Locking Ankle 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 Ankle Nail 14 is substantially equivalent to the predicate devices.

The following tests were performed:

- (1) Static test
- · 4-point bend test of rod
- Torsion test of rod

Dyna Locking Ankle Nail™ "

Image /page/1/Picture/27 description: The image shows the logo for U&I Corporation. The logo is black and white. The letters U&I are in a stylized font, with the ampersand (&) connecting the two letters. To the right of the letters is the word "CORPORATION" in a sans-serif font.

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(2) Dynamic test 4-point bend test of rod ●

3. Conclusion

The data and information provided in this submission support the conclusion that the Dyna Locking Ankle Nail™ is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

1120419(3/3

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle, with three stylized wing feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

U&I Corporation % Mr. Gyeong-Je Kwon Regulatory Affairs Specialist 529-1 Yonghyun-Dong Uijungbu, Kyunggi-do Republic of Korea 480-050

MAY 2 1 2012

Re: K120419

Trade/Device Name: Dyna Locking Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 6, 2012 Received: February 21, 2012

Dear Mr. 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 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.

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## Page 2 - Mr. Gyeong-Je Kwon

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

# 510(k) Number (if known):

Device Name: Dyna Locking Ankle Nail™

## Indications for Use:

The Dyna Locking Ankle Nail™ is used in various indications as follows.

- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis
- Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion .
- Talar deficiency conditions requiring tibiocalcaneal arthrodesis
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint .

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (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)

A.S.S

(Division Sign-Off) Division o Surgical, Orthopedic, and Restorative Devices

510(k) Number K12,0419

Dyna Locking Ankle Nail™

**U&j CORPORATION**