PLAQUAGRAFE, AGRAFE P4V

K974603 · Atlas Technology · HRS · Mar 10, 1998 · Orthopedic

Device Facts

• Record ID: K974603
• Device Name: PLAQUAGRAFE, AGRAFE P4V
• Applicant: Atlas Technology
• Product Code: HRS · Orthopedic
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Deformity of the great toe when it is bent to the outside toward the other toes. Commonly referred and to as: Hallux Valgus Osteotomy or fracture fixation of the small bones of the hand or foot.

Device Story

Plaquagrafe and P4V Agrafe are orthopedic fixation devices; used for osteotomy or fracture fixation of small bones in hand or foot; specifically indicated for Hallux Valgus correction. Devices provide mechanical stabilization of bone segments post-osteotomy or fracture; intended for use by orthopedic surgeons in clinical/surgical settings. Output is physical fixation of bone; aids in bone healing and deformity correction. Benefit is restoration of proper alignment and structural integrity of small bones.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Orthopedic fixation staples/plates for small bone surgery. Mechanical fixation device. Specific materials and ASTM standards not disclosed in provided text.

Indications for Use

Indicated for patients requiring osteotomy or fracture fixation of small bones in the hand or foot, specifically for the correction of Hallux Valgus (bunion) deformity.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Mr. Hillard W. Welch Representative for Atlas Technology 344 Annabelle Point Road Centerville, Massachusetts 02632-2402

Re : K974603 Trade Name: Plaquagrafe and P4V Agrafe Regulatory Class: II Product Codes: HRS and JDR Dated: December 5, 1997 Received: December 10, 1997

Dear Mr. Welch:

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 Requlations, Title 21, Parts 800 to 895. ਜ 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. Hillard W. Welch

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 [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. Whitten, Ph.D.

ia 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

5974603

Device Name: _________________________________________________________________________________________________________________________________________________________________

Deformity of the great toe when it is bent to the outside toward the other toes. Commonly referred and to as: Hallux Valgus

Osteotomy or fracture fixation of the small bones of the hand or foot.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

eed

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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