SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M

K982354 · Special Devices, Inc. · HTN · Nov 23, 1998 · Orthopedic

Device Facts

• Record ID: K982354
• Device Name: SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
• Applicant: Special Devices, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.

Device Story

The SD Trans-Osseous Fastener is a mechanical orthopedic implant designed to stabilize fractured bone fragments. It functions by providing trans-osseous fixation to hold bone segments in apposition during the natural healing process. The device is intended for use by orthopedic surgeons in a clinical or surgical setting. By securing split fractures, such as those occurring in the tibial buttress, the fastener facilitates bone union and provides structural support, potentially reducing the risk of malunion or non-union in the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical bone fastener; trans-osseous design; available in multiple sizes (32/50, 50/80, 80/140).

Indications for Use

Indicated for patients with fractured bone fragments, specifically split fractures such as tibial buttress fractures, requiring fixation during the healing process.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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## NOV 2 3 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph J. Spranza CEO Special Devices, Inc. 12493 Old Rough and Ready Highway Grass Valley, California 95945

K982354 Re: SD Trans-Osseous Fastener Models TOB 6 Bolt 32/50, 50/80, and 80/140 Regulatory Class: II Product Code: HTN October 28, 1998 Dated: Received: November 3, 1998

Dear Mr. Spranza:

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. 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 - Mr. Joseph J. Spranza

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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## Indications for Use.

Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.

Prescription Use . (Per 21 CFR 801.109)

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