2.7MM LCP ULNA OSTEOTOMY SYSTEM

K113364 · Synthes (USA) Products, LLC · HRS · Feb 29, 2012 · Orthopedic

Device Facts

• Record ID: K113364
• Device Name: 2.7MM LCP ULNA OSTEOTOMY SYSTEM
• Applicant: Synthes (USA) Products, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Feb 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Device Story

System consists of 6-hole and 8-hole plates with associated instrumentation for transverse and oblique osteotomy cuts, plate placement, and fixation. Materials include titanium alloy and stainless steel. Used by surgeons in clinical settings for bone stabilization. Provides mechanical support for bone healing; facilitates fixation of fractures, osteotomies, nonunions, replantations, and fusions. Benefits patient by stabilizing bone segments to promote union.

Clinical Evidence

Bench testing only; no clinical data provided. Evidence includes static and dynamic mechanical testing and comparative geometric/material strength analysis.

Technological Characteristics

Materials: titanium alloy and stainless steel. Components: 6-hole and 8-hole plates, surgical instrumentation. Design: LCP (Locking Compression Plate) system. Sterilization: available sterile and non-sterile.

Indications for Use

Indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones/fragments, including osteopenic bone in the ulna. Population: adults and adolescents (12-21 years) with fused growth plates or where growth plates are not crossed by screw fixation.

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

• Modular Mini Fragment LCP System (K063049)
• Synthes Modular Foot System (K001941)
• DC Ulnar Shortening System (K073228)

Submission Summary (Full Text)

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KII3364

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FEB 2 9 2012

## 510(k) Summary

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| Sponsor: | Synthes (USA)<br>Rebecca Blank<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | 2.7mm LCP Ulna Osteotomy System |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories, HRS |
| | Class II, §888.3040 - Smooth or threaded metallic bone fixation<br>fastener, HWC |
| Predicate Device: | K063049- Modular Mini Fragment LCP System<br>K001941- Synthes Modular Foot System (not in comparison table)<br>K073228 - DC Ulnar Shortening System |
| Device Description: | The 2.7mm LCP Ulna Osteotomy System consists of two plates, 6-<br>hole and 8-hole which will be available in titanium alloy and<br>stainless steel, to be offered sterile and non-sterile. This system also<br>includes instrumentation which supports transverse and oblique<br>osteotomy cuts as well as plate placement and fixation. |
| Intended Use: | The 2.7mm LCP Ulna Osteotomy System is indicated for fixation<br>of fractures, osteotomies, nonunions, replantations, and fusions of<br>small bones and small bone fragments, including osteopenic bone<br>in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated<br>for use in both adults and adolescents (12-21 years) in which<br>growth plates have fused or in which growth plates will not be<br>crossed by screw fixation. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence of the<br>Synthes 2.7mm LCP Ulna Osteotomy System to predicate devices.<br>The proposed system has the same indications for use, is similar in<br>design, incorporates the same fundamental product technology and<br>is composed of the same materials. |
| | To additionally support substantial equivalence, static and dynamic<br>bench testing was performed as well as calculations comparing the<br>bending strength of the subject and predicate devices based on<br>geometric analyses and material characteristics, defined in standard |

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Image /page/1/Picture/0 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 body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Synthes (USA) % Ms. Rebecca Blank 1301 Goshen Parkway West Chester, Pennsylvania 19380

FEB 2 9 2012

Re: K113364 Trade/Device Name: 2.7 LCP Ulna Osteotomy System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: February 7, 2012 Received: February 12, 2012

Dear Ms. Blank:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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## Page 2 – Ms. Rebecca Blank

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

Sincerely yours,

Mark N. Molkersen

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

510(k) Number (if known): K113364

Device Name: Synthes (USA) 2.7mm LCP Ulna Osteotomy System

Indications for Use:

The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

AND/OR Prescription Use X _ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

KII3364 510(k) Number.