(65 days)
The Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
Synthes EIN is a flexible intramedullary fixation device. The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm in length, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is made of a titanium alloy (Ti-6Al-7Nb).
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.
The document is a 510(k) summary for the Synthes Elastic Intramedullary Nail (EIN) System, detailing its intended use, classification, and predicate device. It includes the FDA's clearance letter for the device, confirming its substantial equivalence to previously marketed devices.
Therefore, I cannot provide the requested information.
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| ATTACHMENT VII: | Summary of Safety and Effectiveness Info. [510(k) Summary] | ||
|---|---|---|---|
| SUBMITTER | Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri | JUL 18 1997 | |
| COMMON OR USUAL NAME: | Intramedullary fixation rod/pin | ||
| DEVICE CLASSIFICATION | Class II, 21 CFR 888.3020; 888.3040 | ||
| PREDICATE DEVICE: | Landos Nancy Nail (K960642) | ||
| DESCRIPTION: | Synthes EIN is a flexible intramedullary fixation device. The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm in length, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is made of a titanium alloy (Ti-6Al-7Nb). | ||
| INTENDED USE: | The Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) ... .......... 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
JUL 1 8 1997
K971783 Re : Synthes (USA) Elastic Intramedullary Nail (EIN) System Requlatory Class: II Product Code: HTY May 13, 1997 Dated: May 14, 1997 Received:
Dear Ms. Silvestri:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part: 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Angela J. Silvestri
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
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510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
| Division of General Restorative Devices | K971783 |
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| ----------------------------------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | X |
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| ------------------------------------------ | --- |
OR 510(k) Number Over-The-Counter UseOriginal Instruments and Implants of the Association for the Study of Internal Fixation---AO/ASIF
§ 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.