(30 days)
The Synthes (USA) Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.
I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, a study, sample sizes, experts, adjudication methods, multi-reader multi-case studies, standalone performance studies, or ground truth.
The document is a 510(k) summary and an FDA clearance letter for the Synthes (USA) Sternal Fixation System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the detailed study design and results typically found in a clinical trial report.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold black letters, with the registered trademark symbol to the left of the word. To the right of the word is the number "K081700" written in black ink. The date "JUL 17 2008" is written in black ink on the right side of the image.
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| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6604 | |
| Contact: | Amnon TalmorSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6604 | |
| Device Name: | Synthes (USA) Sternal Fixation System-Line Extension | |
| Classification: | Class II per 21 CFR §888.3040: Screw, Fixation, Bone, Metallic | |
| PredicateDevices: | Synthes (USA) Sternal Fixation System | |
| Synthes (USA) Sterile Sternal Fixation System | ||
| DeviceDescription: | The Synthes (USA) Sternal Fixation System consists ofmachined titanium plates, a quick-release pin and 3.0 mmlocking screws. The plates utilize screw fixation to create theconstruct. | |
| Intended Use: | The Synthes (USA) Sternum Fixation System is intended foruse in primary or secondary closure/repair of the sternumfollowing sternotomy or fracture of the sternum to stabilize thesternum and promote fusion. | |
| SubstantialEquivalence: | Documentation is provided that demonstrates the Synthes(USA) Sternal Fixation System - modification to be substantiallyequivalent to other legally marketed devices such as: Synthes(USA) Sternal Fixation System |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal represents the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2008
Synthes (USA) % Mr. Amnon Talmor 1301 Goshen Parkway West Chester, PA 19380
Re: K081700 Trade/Device Name: Synthes (USA) Sternal Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class. Class II Product Code: HWC Dated: June 12, 2008 Received: June 17, 2008
Dear Mr. Talmor:
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 such 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); 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. Amnon Talmor
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities made the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 registered trademark symbol is to the right of the word. The word is underlined with a thin black line.
2.0
| 510(k) Number (if known): | K081700 |
|---|---|
| Device Name: | Synthes (USA) Sternal Fixation System |
| Indications for Use: | The Synthes (USA) Sternal Fixation System is intended for use inprimary or secondary closure/repair of the sternum followingsternotomy or fracture of the sternum to stabilize the sternum andpromote fusion. |
Indications for Use
X Prescription Use (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)
Boubare Buehup
Division of General, Restorative, and Neurological Devices
510(k) Number K081702
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.