DYNA LOCKING CANNULATED SCREW

K112240 · U&I Corp. · HWC · Jan 4, 2012 · Orthopedic

Device Facts

• Record ID: K112240
• Device Name: DYNA LOCKING CANNULATED SCREW
• Applicant: U&I Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intracapsular fractures of the femoral neck . Intertrochanteric fractures of the femur . Tibial plateau fractures . Fractures of the dorsal pelvic ring . Pelvic sacroiliac joint disruption . Ankle arthrodesis . Other indications where cancellous screws are currently used and a guided . system may be beneficial

Device Story

Dyna Locking Cannulated Screw system consists of titanium alloy (Ti-6Al-4V ELI) cannulated screws and washers; used for bone fixation. Screws are inserted over guide pins to facilitate accurate fracture reduction and placement; guide pins allow for percutaneous insertion, potentially reducing surgical morbidity. Washers used when cortical bone is soft or thin. System includes specialized stainless steel instruments for implantation and removal. Intended for use by surgeons in clinical/OR settings. Benefits include precise screw placement and provisional fracture fixation via guide pins.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance evaluated via engineering analyses of pull-out, bending, and torsional strength compared to predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Components: Cannulated screws and washers. Instrumentation: Surgical grade stainless steel. Design: Cannulated for over-the-wire placement. Sterilization: Non-sterile (supplied).

Indications for Use

Indicated for patients requiring bone fixation for intracapsular femoral neck fractures, intertrochanteric femur fractures, tibial plateau fractures, dorsal pelvic ring fractures, pelvic sacroiliac joint disruption, ankle arthrodesis, or other conditions where cancellous screws and guided systems are appropriate.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Richards Cannulated Screw (K951389)
• Synthes Cannulated Screw (K962823)
• Synthes Cannulated Screw (K963192)
• Synthes Cannulated Screw (K963172)
• Synthes Cannulated Screw (K021932)
• Synthes Cannulated Screw (K962011)

Submission Summary (Full Text)

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# 12 KII2240

# JAN - 4 2012

# 5. 510(k) Summary

| Manufacturer: | U & I Corporation<br>529-1, Yonghyun-dong, Uijungbu<br>Kyunggi-Do, Korea 480-050<br>Gyeong-Je Kwon, Regulatory Affairs Specialist |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 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: | August 01, 2011 |
| Device Name: | Trade Name: Dyna Locking Cannulated Screw™™ |
| Common Name: | Bone Fixation Screws |
| Classification Name: | 21 CFR 888.3040 - Smooth or threaded metallic bone<br>fixation fastener |
| Product Code: | HWC - Screw, Fixation, Bone |
| Predicate Devices: | Richards Cannulated Screw (K951389)<br>Synthes Cannulated Screw (K962823, K963192, K963172,<br>K021932, K962011) |

### Description of Device:

The Dyna Locking Cannulated Screw™ consists of various sizes of cannulated screws and washers. Cannulated screws are designed to be inserted over guide pins and provide several potential benefits over standard screws especially the precision with which they can be placed. Guide pins can be used for provisional fracture fixation, facilitating accurate fracture reduction before definitive fixation with screws. In addition, the guide pins can be placed percutaneously with potential benefits of decreased surgical morbidity. A washer may be used as an extension of the cannulated screw where the cortical bone is soft or thin.

All implants of Dyna Locking Cannulated Screw™ are single use device, supplied

Dyna Locking Cannulated Screw™

**U&i** CORPORATION

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non-sterile and manufactured from titanium alloy(Ti-6AI-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 Cannulated Screw™.

#### Intended Use:

- Intracapsular fractures of the femoral neck .
- Intertrochanteric fractures of the femur .
- Tibial plateau fractures .
- Fractures of the dorsal pelvic ring .
- Pelvic sacroiliac joint disruption .
- Ankle arthrodesis .
- Other indications where cancellous screws are currently used and a guided . system may be beneficial

#### Substantial Equivalence:

The Dyna Locking Cannulated Screw™ is substantially equivalent to Richards Cannulated Screw(K951389) and Synthes Cannulated Screw(K962823, K963192, K963172, K021932, K962011) in design, material, mechanical performance, function and intended use. Engineering analyses of pull-out, bending, and torsional strength were conducted based on geometric/material comparison to predicate devices.

**Dyna Locking Cannulated Screw**™

**U&i** CORPORATION

K112242

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

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, Korea 480-050

JAN - 4 2012

Re: K112240

Trade/Device Name: Dyna Locking Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 16, 2011 Received: December 20, 2011

Dear Mr. Kwon:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indication We nave reviewed your becaon 910(t) pressessed is substantially equivalent (for the indications ferenced above and nave determined and and and and and one smarketed in interstate for use stated in the citilosure/to regars actment date of the Medical Device Americal Device commence prof to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have occh recuired in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appear the general controls provisions of the Act. The Y ou may, ulerefore, market the devices, basjon to unements for annual registration, listing of general controls provisions of mactice, labeling, and prohibitions against misbranding and devices, good manufacturing practices, as starting and on related to contract liability adulteration. TTCase note: "CDTC" accorner 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 If your device is classified (boo acove) Existing major regulations affecting your device can be may be subject to additional controls. "Billeting and the 200 to 898. In addition, FDA may fouria in the South of I concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled on a bucked on a case and other requirements of the Act
that FDA has made a determination that your device complies with other matt that I DA has made a determination administered by other Federal agencies. You must of ally rederal statutes and regulations and and limited to: registration and listing (21 comply with an the Act 3 requirements, and 801); medical device reporting (reporting of medical

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### Page 2 - Mr. Gyeong-Je Kwon

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de neceretation adverse overies (21 CFR Part 820); and if applicable, the electronic forth in the qualisms by the estimal (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 11 you desire spectiv as reading a l Centers Offices/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 Tou may 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin Keith

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): K112240

Device Name: Dyna Locking Cannulated Screw™

### Indications for Use:

- Intracapsular fractures of the femoral neck ●
- Intertrochanteric fractures of the femur .
- Tibial plateau fractures .
- Fractures of the dorsal pelvic ring .
- Pelvic sacroiliac joint disruption .
- Ankle arthrodesis .
- Ankle arthreations where cancellous screws are currently used and a guided . system may be beneficial

Over-The-Counter Use × Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hthind for

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

**510(k) Number**

**U&i** CORPORATION

Dyna Locking Cannulated Screw™