(28 days)
As part of the Synthes Trochanteric Fixation Nail (TFN) System, the Synthes TFN Screw 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.
The Synthes TFN Screw is a threaded component composed of titanium alloy which is intended for use with Synthes Trochanteric Fixation Nails to provide stabilization of fractures of the proximal femur.
This document is a 510(k) summary for the Synthes (USA) Trochanteric Fixation Nail (TFN) Screw. It is a regulatory submission for a medical device and, as such, outlines the device's technical specifications, intended use, and substantial equivalence to predicate devices. It does not present a study proving the device meets acceptance criteria in the context of an AI/software as a medical device (SaMD) or diagnostic tool.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies because this document does not contain that type of information.
The document is a filing for an orthopedic screw, a physical medical device, not a diagnostic or AI-powered system that would typically undergo performance studies with the metrics you've listed.
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510(k) Summary 3.0
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941 |
|---|---|
| SEP 2 5 2009 | |
| Device Name: | Synthes (USA) Trochanteric Fixation Nail (TFN) Screw |
| Classification: | Class II, §888.3020 - Intramedullary fixation rod. |
| Predicate Device: | Synthes Trochanteric Fixation Nail (TFN) SystemStryker® Gamma3™ Nail System |
| Device Description: | The Synthes TFN Screw is a threaded component composed oftitanium alloy which is intended for use with Synthes TrochantericFixation Nails to provide stabilization of fractures of the proximalfemur. |
| Intended Use: | As part of the Synthes Trochanteric Fixation Nail (TFN) System,the Synthes TFN Screw is intended to treat stable and unstablefractures of the proximal femur including pertrochanteric fractures,intertrochanteric fractures, basal neck fractures, and combinationsthereof. The Long TFN is additionally indicated for subtrochantericfractures, pertrochanteric fractures associated with shaft fractures,pathologic fractures (including prophylactic use) in bothtrochanteric and diaphyseal regions, long subtrochanteric fractures,proximal or distal non-unions, malunions, and revisions. |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Karl J. Nittinger Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
SEP 2 5 2009
Re: K092646
Trade/Device Name: Synthes (USA) Trochanteric Fixation Nail (TFN) Screw Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB, HWC Dated: August 27, 2009 Received: August 28. 2009
Dear Mr. Nittinger:
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. Karl J. Nittinger
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,
Harboufmiens
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):
Device Name:
2.0
Synthes (USA) Trochanteric Fixation Nail (TFN) Screw
Indications for Use:
As part of the Synthes Trochanteric Fixation Nail (TFN) System, the Synthes TFN Screw 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)
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)
Oonute for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092646
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.