(80 days)
The Howmedica® Titanium Hoffmann® Fixation Pin System is intended to be used in conjunction with a rigid external supporting frame for immobilization open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
The Howmedica® Titanium Hoffmann® Fixation Pin System consists of half pins and transfixing pins available in a range of overall lengths, thread lengths and in shank diameters ranging from 1.5mm to 6mm. The half pins and transfixing pins are available in self-drilling and blunt tip configurations. The Howmedica® Titanium Hoffmann® Fixation Pins are designed to ease bone penetration and minimize risk of friction thermal necrosis, thereby facilitating secure bone purchase and stable fixation of the fracture.
The Howmedica® Titanium Hoffmann® Fixation Pins are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures.
This document is a 510(k) summary for a medical device called the Howmedica® Titanium Hoffmann® Fixation Pin System. It describes the device, its intended use, and states that its substantial equivalence to previously marketed devices is based on equivalence in intended use, materials, design, and operational principles.
However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is primarily a regulatory filing (510(k)) indicating that the device has been found substantially equivalent to predicate devices, allowing it to be marketed. It does not include the detailed technical study information you've requested.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.
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| AUG 31 1998 | 510(k) Summary |
|---|---|
| Proprietary Name: | Howmedica® Titanium Hoffmann® Fixation PinSystem |
| Common Name: | External Fixation System |
| Classification Name &Reference: | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
| Proposed Regulatory Class: | II |
| Device Product Code: | JDW OR(87) |
| For information contact: | Sean LulandRegulatory Affairs AssociateHowmedica Inc.359 Veterans BoulevardRutherford, NJ 07070Phone: (201) 507-7437Fax: (201) 507-6870 |
The Howmedica® Titanium Hoffmann® Fixation Pin System consists of half pins and transfixing pins available in a range of overall lengths, thread lengths and in shank diameters ranging from 1.5mm to 6mm. The half pins and transfixing pins are available in self-drilling and blunt tip configurations. The Howmedica® Titanium Hoffmann® Fixation Pins are designed to ease bone penetration and minimize risk of friction thermal necrosis, thereby facilitating secure bone purchase and stable fixation of the fracture.
The Howmedica® Titanium Hoffmann® Fixation Pins are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to the currently marketed Howmedica® Hoffmann® Fixation Pin System and the Smith & Nephew-Richards Titanium Alloy Half Pins.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 1998
Mr. John F. Dichiara Director, Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K982068 Re: Howmedica® Titanium Hoffmann® Trade Name: Fixation Pin System Regulatory Class: II Product Code: JDW Dated: June 11, 1998 Received: June 12, 1998
Dear Mr. Dichiara:
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 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 (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. ਚੋ 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. John F. Dichiara
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
Director Division of General 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): ├ 익§ڃ८६८
Device Name: The Howmedica® Titanium Hoffmann® Fixation Pin System
Indications for Use:
The Howmedica® Titanium Hoffmann® Fixation Pin System is intended to be used in conjunction with a rigid external supporting frame for immobilization open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR × (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices, K982068
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.