(86 days)
Fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand
The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The provided text is a 510(k) summary and approval letter for the OsteoMed Auto-Drive Bone Screw, focusing on its substantial equivalence to previously marketed devices. It describes the device's intended use, materials, design, and operational principle, and states that equivalence is based on these similarities. It does not contain any details about a study conducted to prove the device meets specific acceptance criteria in terms of performance metrics.
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MAR 18 1998
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
Contact Person:
510(k) Summary
OsteoMed Auto-Drive Bone Screw
Small Bone Screw
Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040
OsteoMed Corporation
Bruce Horowitz Manager, Regulatory Affairs/Quality OsteoMed Corp. 3750 Realty Road Dallas, TX 75244 Telephone: (972) 241-3401 FAX: (972) 241-3507
12/19/97
Date Prepared:
Summary:
This submission describes the Auto-Drive™ bone screws intended for use in internal fixation of small bones including the cranifacial and maxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-free™ Screw (K944565) and the Leibinger® Self-Drilling Screw (K970912). All of the screw systems are intended for use in internal fixation of small bones including the cranifacial and maxillofacial skeleton and hand, secondary to trauma or for reconstruction. All of the screws are self drilling and manufactured from Titanium alloy. The basic operational principle is the same for all three screws, e.g., they are self drilling and can be inserted in one step. Indications are also equivalent for each of the devices.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol, with three distinct head profiles overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
MAR 1 8 1998
Mr. Bruce R. Horowitz Manager, Requlatory Affairs/Quality Assurance OsteoMed Corporation 3750 Realty Road Dallas, Texas 75244
K974785 Re: Auto-Drive Bone Screw Trade Name: Regulatory Class: II Product Code: HWC Dated: December 19, 1997 December 22, 1997 Received:
Dear Mr. Horowitz:
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. ਜੋ 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. Bruce R. Horowitz
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeirbed in your alence of your device to a legally marketed predicate device results in a classification for your marketed predicate acits 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 ocalpiration 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,
Nussell J. Ryan
A 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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OSTEOMED "Indications for Use" Submission
510(k) Number:
. .
| Device Name: | Osteomed Auto-Drive Bone ScrewSmooth or threaded metallic bone fixationfastener |
|---|---|
| Indication for Use: | Fixation secondary to trauma orreconstruction of the craniofacial andmaxillofacial skeleton and bones of thehand |
Prescription Use
(Per 21 CFR 801.109)
Thurrell P. Tyson
(Division Sign-Off)
fir ﮨﺮﮮ Division of General Restorative Devices 1974785 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.