(52 days)
Intended Use:
Fixation of bone fragments
Indications For Use:
-
- Bone fractures
-
- Bone reconstructions
-
- Bone traction
Not Found
The provided text is a 510(k) Premarket Notification for a medical device called "The Bone Tie." This type of document is for regulatory approval and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The 510(k) submission process is primarily about demonstrating "substantial equivalence" to a predicate device already on the market, rather than proving the device meets specific performance acceptance criteria through a clinical study. It focuses on the device's design, materials, and intended use being similar to an already approved device.
Therefore, I cannot provide the requested information based on the input text. The document describes:
- Device Name: THE BONE TIE
- Intended Use/Indications For Use: Fixation of bone fragments for bone fractures, bone reconstructions, and bone traction.
- Classification: Class II, Product Code HTY, as a "Smooth or threaded metallic bone fixation fastener."
- Regulatory Approval: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
To answer your request, I would need a different type of document, such as a clinical study report or a detailed design verification and validation document, which would explicitly describe acceptance criteria and present study results against those criteria.
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SEP 2 5 1998
1982719
| Section 510(k) Premarket NotificationSURGICRAFT, LIMITED | Summary of Safety and Effectiveness Information forThe Bone Tie |
|---|---|
| -------------------------------------------------------------- | --------------------------------------------------------------------- |
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
1. Device Name:
THE BONE TIE TRADE NAME:
Bone fixation implant Common Name:
Appliance, Fixation, Bone fixation Interlaminar Classification Name:
2. Establishment Name & Registration Number:
Name: SURGICRAFT, LTD.
Number: 8020712
3. Classification:
§ 888.3040 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-molbdenum 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.
Product Code: HTY
Device Class: Class II
Orthopaedics and rehabilitation devices panel Classification Panel:
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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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 1998
Mr. Simon Fitzer Surgicraft Ltd. Fishing Line Road Redditch, Worcestershsire B97 6HF, England
Re : K982719 Trade Name: The Bone Tie Regulatory Class: II Product Code: HTY Dated: July 24, 1998 Received: Aaugust 4, 1998
Dear Mr. Fitzer:
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, Drug, 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. ਉ 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 action. In addition, FDA may publish further announcements 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 regulations.
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Page 2 - Mr. Simon Fitzer
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 requlation 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 at (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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Page 1______________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: THE BONE TIE
Intended Use:
Fixation of bone fragments
Indications For Use:
-
- Bone fractures
-
- Bone reconstructions
-
- Bone traction
PLEASE DO NOT WRITE: BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | L982719 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional format 1-2-96) |
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.