(62 days)
The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.
The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.
I apologize, but the provided text from the 510(k) summary (K982931) for the "Threaded Fixation Pin" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
This 510(k) summary is a declaration of substantial equivalence to predicate devices, focusing on the device's intended use and design similarities, rather than detailed performance study results.
Therefore, I cannot populate the requested table or answer the specific questions about studies and data provenance based on this document. The document primarily acts as an FDA clearance letter and an "Indications for Use" statement.
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510(k) SUMMARY - Safety and Effectiveness
X982931
Threaded Fixation Pin
The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Thomas Sgarlato, DPM Sqarlato Laboratories, Inc. 250 Almendra Avenue Los Gatos, California 95030
K982931 Re: Trade Name: Threaded Fixation Pin Regulatory Class: II Product Code: JDW September 30, 1998 Dated: October 8, 1998 Received:
Dear Dr. Sqarlato:
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 Requlations, 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 requlation (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 regulations.
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Page 2 - Thomas Sgarlato, DPM
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 requlation (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.qov/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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INDICATIONS FOR USE
510(k) Number (if known): ___K982931
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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(Divisi n Sian-Off Division of General Restorativ K98293 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.