HYPROCURE SUBTALAR IMPLANT SYSTEM

K042030 · Graham Medical Technologies, LLC · HWC · Sep 16, 2004 · Orthopedic

Device Facts

• Record ID: K042030
• Device Name: HYPROCURE SUBTALAR IMPLANT SYSTEM
• Applicant: Graham Medical Technologies, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This device is prescription use only.

Device Story

HyProCure Subtalar Implant System is a metallic bone fixation fastener; used for stabilization of subtalar joint in hyperpronated feet. Implant blocks anterior, medial, and/or plantarflexion of talus; allows normal subtalar joint motion while restricting excessive pronation. Device is surgically implanted by a physician; intended to treat sequelae of hyperpronation. Benefits include mechanical stabilization of joint and correction of foot alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; intended for subtalar joint stabilization. Class II device under 21 CFR 888.3040. No specific material standards or software components described.

Indications for Use

Indicated for treatment of hyperpronated foot in patients requiring subtalar joint stabilization. Prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Michael E. Graham, DPM Chief Executive Officer Graham Medical Technologies, LLC 45700 Schoenherr Road Shelby Township, Michigan 48315

Re: K042030

Trade/Device Name: HyProCure Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 23, 2004 Received: July 28, 2004

Dear Dr. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious your beenmined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 2017 - 11:51
devices that have been reclassified in accordance with the provisions of the Federal Food, DINA de neces that have been require approval of a premarket approval application (PMA). and Cosmetter For (110) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, there, mans of the Act include requirements for annual registration, listing of general bonuroly provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinou toontrols. Existing major regulations affecting your device can Inay be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devised that I Drivision that your device complies with other requirements of the Act that I Dri has intates and regulations administered by other Federal agencies. You must of any I catales and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Far 6077, lacemig (21 (OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byovens (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Michael E. Graham, DPM

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematics notification: "The stars 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), please If you desire specific acrise is. Jour 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionmance and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use:

## 510(k) Number: K042030 HYPROCURE SUBTALAR IMPLANT SYSTEM Device Name:

The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

This device is prescription use only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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