SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)

{0}------------------------------------------------ FEB - 8 2012 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. A small registered trademark symbol is located to the right of the letter "S" in the word "SYNTHES". K120083 | 3.0<br>510(k) Summary | Page 1 of 1 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Synthes<br>Thomas N. Shea<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>(610) 719-6809 | | Device Name: | Set Screw for Ti Trochanteric Fixation Nail (TFN) | | Classification: | Product Code – HSB/HWC, Rod, Fixation, Intramedullary and<br>Accessories, Class II, §888.3020 - (Intramedullary fixation rod.) | | Predicate Devices: | Synthes Trochanteric Fixation Nail (TFN) Screw K092646<br>Synthes Trochanteric Fixation Nail (TFN) K011857<br>Smith & Nephew, Inc. TriGen InterTAN° K040212 | | Device Description: | The Set Screw for Ti Trochanteric Fixation Nail (TFN) is an<br>additional offering for use with the existing TFN System. The Set<br>Screw prevents sliding and rotation of the head element (TFN Screw<br>or helical blade) within the nail for fixation of proximal femur<br>fractures. | | Intended Use: | The Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to<br>treat stable and unstable fractures of the proximal femur including<br>pertrochanteric fractures, intertrochanteric fractures, basal neck<br>fractures and combinations thereof. The long TFN is additionally<br>indicated for subtrochanteric fractures, pertrochanteric fractures<br>associated with shaft fractures, pathologic fractures (including<br>prophylactic use) in both trochanteric and diaphyseal regions, long<br>subtrochanteric fractures, proximal or distal non-unions, malunions,<br>and revisions. | | Substantial<br>Equivalence: | Information presented supports substantial equivalence of the Set<br>Screw for Ti Trochanteric Fixation Nail (TFN) to the predicate<br>devices, Synthes Trochanteric Fixation Nail, Synthes Trochanteric<br>Fixation Nail Screw, and the Smith & Nephew, Inc. TriGen<br>InterTAN°. The proposed set screw has the same indications for use,<br>is similar in shape/design and incorporates the same fundamental<br>technology.<br>Axial static testing was conducted to demonstrate the comparable<br>mechanical performance of the subject device, Set Screw for Ti TFN<br>compared to the predicate. The mechanical testing was designed to<br>assess the peak slip load of the proposed device. | device is substantially equivalent to the predicate. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Synthes % Mr. Thomas Shea Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380 FEB - 8 2012 Re: K120083 Trade/Device Name: Set Screw for Ti Trochanteric Fixation Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod. Regulatory Class: Class II Product Code: HSB, HWC Dated: January 10, 2012 Received: January 12, 2012 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {2}------------------------------------------------ ## Page 2 - Mr. Thomas Shea 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/ResourcesforYou/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 {3}------------------------------------------------ Image /page/3/Picture/0 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. A small circle with an R inside is located to the right of the word. 2.0 Indications for Use 510(k) Number (if known): _ K120083 Device Name: Set Screw for Ti Trochanteric Fixation Nail (TFN) Indications for Use: The Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. Prescription Use X (Per 21 CFR 801.109) 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) BAPinder (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices AND/OR 510(k) Number_K120083