HyProCure II

K142534 · Graham Medical Technologies, LLC Dba Gramedica · HWC · Oct 3, 2014 · Orthopedic

Device Facts

• Record ID: K142534
• Device Name: HyProCure II
• Applicant: Graham Medical Technologies, LLC Dba Gramedica
• Product Code: HWC · Orthopedic
• Decision Date: Oct 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

Device Story

HyProCure II is a sinus tarsi implant designed to stabilize the talus on the tarsal mechanism. The device is surgically inserted into the sinus tarsi to prevent excessive anterior, medial, and plantarflexion of the talus while preserving normal talotarsal joint motion. It is intended for use by orthopedic surgeons or podiatrists in a clinical or surgical setting to treat hyperpronating instability of the hindfoot. The device functions as a mechanical stabilizer; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data provided; non-clinical performance testing was deemed unnecessary to demonstrate substantial equivalence.

Technological Characteristics

Sinus tarsi implant; metallic bone fixation fastener (Class II, 21 CFR 888.3040). Design and material choices are consistent with the predicate device. Mechanical stabilization principle; no energy source, software, or connectivity.

Indications for Use

Indicated for patients with hyperpronating instability of the hindfoot requiring stabilization of the talus.

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.

Predicate Devices

• HyProCure Subtalar Implant System (K042030)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Graham Medical Technologies, L.L.C. dba GraMedica October 3, 2014 % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K142534

Trade/Device Name: HyProCure II (HYP II and HYP IIs) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 5, 2014 Received: September 9, 2014

Dear Dr. Linda Braddon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Linda Braddon

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K142534

Device Name HyProCure II (HYP II and HYP IIs)

Indications for Use (Describe)

HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the GraMedica HyProCure II is provided below.

| Date Summary Prepared | September 5, 2014 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>/ Distributor<br>/ Sponsor | GraMedica<br>16137 Leone Drive<br>Macomb, MI 48042<br>586-677-9600 (office)<br>586-677-9615 (fax)<br>[e-mail] (email) |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681 (direct)<br>855-MED-DEV1 (office)<br>[e-mail] |
| Trade Name | HyProCure II (HYP II and HYP IIs) |
| Common Name | Sinus Tarsi Implant |
| Code -Classification | HWC 21 CFR 888.3040 : Class II |
| Predicate Devices | K042030 HyProCure Subtalar Implant System |
| Device Description | The HyProCure II is an implant which stabilizes the talus on the tarsal<br>mechanism. The system consists of an implant designed to be inserted into<br>the sinus tarsi and corresponding instrumentation to facilitate insertion. |
| Intended Use | HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the<br>treatment of hyperpronating instability of the hindfoot. The implant is<br>designed to stabilize the talus to prevent excessive anterior, and/or medial,<br>and/or plantarflexion of the talus, while allowing normal talotarsal joint<br>motion. |
| Technological Characteristics | HyProCure II is of similar sizes, material choices and configurations as<br>compared to the predicate. |
| Non-Clinical Performance<br>Testing Conclusion | Non-clinical data was not necessary to show substantial equivalence |
| Substantial Equivalence<br>Summary (Conclusion) | Based on the indications for use, technological characteristics, and<br>comparison to predicate devices, the HyProCure II system has been shown<br>to be substantially equivalent to legally marketed predicate devices, and safe<br>and effective for its intended use. |