BONE SCREWS

K990351 · Bregma International Trading Company , Ltd. · HWC · Jun 1, 1999 · Orthopedic

Device Facts

• Record ID: K990351
• Device Name: BONE SCREWS
• Applicant: Bregma International Trading Company , Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.

Device Story

Bone screws used for orthopedic fracture fixation and bone plate attachment. Three variants: cortical (compact bone), cancellous (spongy bone), and cannulated (wire-guided). Used by surgeons in clinical/OR settings. Mechanical fixation device; provides structural stability to bone fragments during healing. No electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Mechanical orthopedic bone screws. Variants include cortical, cancellous, and cannulated designs. Materials and specifications not detailed in provided text. Non-electronic, non-powered, manual surgical instrumentation.

Indications for Use

Indicated for fixation of fractured long and short bones and fastening of bone plates. Cortical screws for compact/hard diaphyseal bone; cancellous screws for soft/spongy epiphyseal and metaphyseal bone; cannulated screws for procedures requiring surgical wire guidance.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Ms. Shimona Petroff Vice President Bregma International Trading Company Limited 214-111 Research Drive, Innovation Place Saskatoon, Saskatchewan Canada S7N 3R2

K990351 Re: Bone Screws Trade Name: Regulatory Class: II Product Code: HWC K990353 Kirschner Wire and Steinman Pin Trade Name: Regulatory Class: II Product Codes: JDW and HTY March 31, 1999 Dated: March 31, 1999 Received:

Dear Ms. Petroff:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action.

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Page 2 - Ms. Shimona Petroff

concerning your devices 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.

This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (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 devices, 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

Enclosures

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IHI: 08:29 EAX 301 180 1237 05/20/88

CDRH DRAERI

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510(k) Nunber (if known): K990351

Device Name; Bone Screws

Indications For Use:

Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.

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Concurrence of CDRH, Office of Device Evaluation (ODD)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-95)

of General Restorative De