← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K142478 # opti-Toe (K142478) _Graham Medical Technologies, LLC (D.B.A.Gramedica) · HTY · May 29, 2015 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K142478 ## Device Facts - **Applicant:** Graham Medical Technologies, LLC (D.B.A.Gramedica) - **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md) - **Decision Date:** May 29, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing or heel weight-bearing only until soft tissue healing has occurred. ## Device Story The opti-Toe is an intramedullary fixation device for lesser toe reconstruction. It consists of two mated components (proximal and middle phalangeal) that are cemented in place to form a single unit. The device is available in two sizes, with the middle component offered in straight or 10-degree angled configurations. It is intended for use by surgeons in clinical settings to stabilize toes following hammertoe, claw toe, or mallet toe correction procedures. The device provides mechanical fixation to support the toe during the soft tissue healing process, after which patients may resume weight-bearing. ## Clinical Evidence No clinical data provided. Evidence consists of bench testing, including cadaveric simulated use studies, assembly/disassembly force testing, and static/dynamic bending mechanical performance evaluations. ## Technological Characteristics Intramedullary fixation device consisting of two mated components. Available in two sizes with optional 10-degree angulation. Requires cement for fixation. Mechanical performance evaluated via static and dynamic bending tests. ## Regulatory 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 - NextraTM Ti Hammertoe Correction System ([K122031](/device/K122031.md)) - ProxiFuse Hammer Toe Device ([K142490](/device/K142490.md)) ## Reference Devices - StayFuse ([K990804](/device/K990804.md)) - DePuy K-Wire ([K960385](/device/K960385.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 26, 2015 Graham Medical Technologies, LLC (d.b.a.GraMedica) % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K142478 Trade/Device Name: opti-Toe Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 27, 2015 Received: April 28, 2015 Dear Dr. Braddon: This letter corrects our substantially equivalent letter of May 29, 2015. 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 {1}------------------------------------------------ Page 2 - Linda Braddon, Ph.D. (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 forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K142478 Device Name opti-Toe Indications for Use (Describe) The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|--| |
× Prescription Use (Part 21 CFR 801 Subpart D)
| | |
Over-The-Counter Use (21 CFR 801 Subpart C)
| | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510 (k) Summary In accordance with 21 CFR 807.87 (h) and 21 CFR 807.92, the 510(k) summary for the GraMedica opti-Toe is provided below. | Date | 5/22/2015 | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor | GraMedica
16137 Leone Drive
Macomb, MI 48042
586-677-9600 (office)
586-677-9615 (fax)
ARecchia@GraMedica.com (email) | | 510(k) Contact | Secure BioMed Evaluations
Linda Braddon, Ph.D.
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681 (direct)
855-MED-DEV1 (office)
LGB@SecureBME.com | | Trade Name | opti-Toe | | Common Name | Pin, fixation, smooth | | Code—Classification | HTY 21 CFR 888.3040 : Class II | | Predicate Devices | K122031 NextraTM Ti Hammertoe Correction System
K142490 ProxiFuse Hammer Toe Device | | Reference Devices | K990804 StayFuse
K960385 DePuy K-Wire | | Device Description | The GraMedica opti-Toe is comprised of two mated components (proximal
and middle phalangeal) which join together to form a single intramedullary
fixation unit. The implants are offered in two sizes, small and large, and the
middle phalangeal component is offered with and without a 10 degree
angulation. | | Intended Use | The GraMedica opti-Toe Device is indicated for reconstruction of the lesser
toes following correction procedures for hammertoe, claw toe, and mallet
toe. The GraMedica opti-Toe components are to be cemented in place and
assembled for reconstruction of the toe. Patients should protect their
weight-bearing or heel weight-bearing only until soft tissue healing has
occurred. | | Technological
Characteristics | The GraMedica opti-Toe is of similar sizes, material choices and
configurations as compared to the predicate. The GraMedica opti-Toe is to
be cemented. | | Non-Clinical
Performance Testing
Conclusion | The GraMedica opti-Toe was tested for clinical ease of use via:
• Cadaveric Simulated Use Study
• Assembly force
• Disassembly force

Additionally, mechanical performance was evaluated via:
• Static and dynamic bending | | Substantial
Equivalence Summary | Based on the indications for use, technological characteristics, and
comparison to predicate devices, the GraMedica opti-Toe is shown to be | {4}------------------------------------------------ | (Conclusion) | substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use. | |--------------|--------------------------------------------------------------------------------------------------------------| |--------------|--------------------------------------------------------------------------------------------------------------| --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K142478](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K142478) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com