SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

K111540 · Synthes (Usa) · HRS · Aug 8, 2011 · Orthopedic

Device Facts

• Record ID: K111540
• Device Name: SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Aug 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Device Story

System consists of metallic plates and screws providing screw-to-plate locking for clavicle fracture fixation. Used by surgeons in clinical settings to stabilize bone segments. Device provides mechanical support to facilitate healing of fractures, malunions, non-unions, and osteotomies. Benefits include rigid fixation and anatomical alignment of clavicular bone.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing assessed bending strength compared to predicate devices to demonstrate substantial equivalence.

Technological Characteristics

Metallic bone fixation system composed of stainless steel and titanium alloy. Features screw-to-plate locking mechanism. Designed for clavicle fracture fixation. No software or electronic components.

Indications for Use

Indicated for fixation of clavicle fractures, malunions, non-unions, and osteotomies in adults, adolescents (12-18 years), and transitional adolescents (18-21 years) where growth plates are fused or will not be crossed by the device.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System (K101536)
• Synthes 3.5mm LCP Clavicle Plate System (K073186)
• Synthes Small Fragment Dynamic Compression Locking System (K000684)

Submission Summary (Full Text)

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K111540

Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a small "R" in a circle to the right of the word, indicating that it is a registered trademark.

AUG - 8 2011

## 3.0 510(k) Summary

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Date Prepared: May 31, 2011

| Sponsor: | Synthes (USA)<br>Thomas N. Shea<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes 3.5mm LCP Clavicle Plate System |
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone fixation<br>appliance and accessories. |
| Predicate<br>Devices: | Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System (K101536) |
| | Synthes 3.5mm LCP Clavicle Plate System (K073186) |
| | Synthes Small Fragment Dynamic Compression Locking System<br>(K000684) |
| Device<br>Description: | The Synthes 3.5mm LCP Clavicle Plate System consists of metallic<br>plates and screws that offer screw to plate locking designed for various<br>fracture modes of the clavicle. |
| Intended Use: | The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation<br>of fractures, malunions, non-unions, and osteotomies of the clavicle in<br>adults, and in both adolescents (12-18 years) and transitional adolescents<br>(18-21 years), in which the clavicular growth plates have fused or in<br>which the growth plates will not be crossed by the plate system. |
| Substantial<br>Equivalence: | The features of the subject components are substantially equivalent to<br>the predicate devices based on similarities in intended use and design.<br>Mechanical testing demonstrates substantial equivalence of the subject<br>components to the predicate devise in terms of mechanical strength. In<br>addition, the intended use, manufacturing methods, packaging, and<br>sterilization of the predicate and subject components are identical. |
| | The subject and predicate devices are made from stainless steel and<br>titanium alloy. Functional and mechanical testing demonstrates the<br>comparable mechanical & functional properties of the subject Synthes<br>3.5mm LCP Clavicle Plate System to the predicate devices. |
| | Testing conducted to support the substantial equivalence for the Synthes<br>3.5mm LCP Clavicle Plate System was performed to assess the bending<br>strength of the subject device compared to the predicate. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Synthes (USA) % Mr. Thomas N. Shea Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

AUG - 8 2011

Re: K111540

Trade/Device Name: Synthes 3.5mm LCP Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: May 31, 2011 Received: June 2, 2011

Dear Mr. Shea:

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

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Page 2 - Mr. Thomas N. Shea

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" (2111,Free) 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.

ea

M

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

Enclosure

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2.0

Indications for Use

510(k) Number (if known): _ KJ11540

Device Name: Synthes 3.5mm LCP Clavicle Plate System

Indications for Use:

The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Prescription Use __ X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Mellersm

(Division Sign-Off (Division Sigh on Sign of Orthopedic, Division of Restorative Devices

510(k) Number K111540

Premarket Notification 510(k): Synthes 3.5mm LCP Clavicle Plate System