← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K160194 # StarFuse Interphalangeal Pin (K160194) _Phalanx Innovations · HTY · Apr 26, 2016 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K160194 ## Device Facts - **Applicant:** Phalanx Innovations - **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md) - **Decision Date:** Apr 26, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes. ## Device Story StarFuse Interphalangeal Pin is an intramedullary bone fixation fastener used for lesser toe digit correction. Device is available in various diameters (3-4 mm) and lengths (16-30 mm), with straight or pre-bent configurations. Implanted by orthopedic surgeons during surgical procedures to facilitate bone fusion. Device provides mechanical stabilization of bone segments during the healing process. Benefits include structural support for osteotomies and reconstruction procedures. ## Clinical Evidence Bench testing only. Static and dynamic 3-point bending testing performed per ASTM F1264-14 confirmed the device performs as intended. ## Technological Characteristics Metallic bone fixation fastener made of 316LVM Stainless Steel (ASTM F138). Available in diameters 3-4 mm and lengths 16-30 mm. Straight or pre-bent form factors. Mechanical fixation device. ## 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 - ARROW-LOK Digital Fusion System ([K112675](/device/K112675.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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 26, 2016 Phalanx Innovations % Ms. Cheryl Wagoner Principal Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408 Re: K160194 Trade/Device Name: StarFuse Interphalangeal Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 8, 2016 Received: April 11, 2016 Dear Ms. Wagoner: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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" (21 CFR 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, # Mark N. Melkerson -S 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) K160194 Device Name StarFuse Interphalangeal Pin Indications for Use (Describe) The StarFuse Interphalangeal Pin is indicated for use with osteotomies, and reconstruction procedures involving the correction of the lesser digits of the toes. | 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) #### 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 ### (as required by 21 CFR 807.92) | Date Prepared | April 8, 2016 | |----------------|-------------------------------| | Manufacturer | Phalanx Innovations | | Address | 200 Cobb Pkwy N | | | Building 200, Suite 210 | | | Marietta, GA 30062 | | Telephone | 888-404-3980 Ext 101 | | Fax | 678-669-2188 | | Contact Person | Daniel Lanois | | | General Manager | | Address | Phalanx Innovations | | | 200 Cobb Pkwy N | | | Building 200, Suite 210 | | | Marietta, GA 30062 | | Telephone | 888-404-3980 Ext 101 | | Fax | 678-669-2188 | | email | daniel@phalanxinnovations.com | | Trade Name | StarFuse Interphalangeal Pin | | |---------------------------------|----------------------------------------------------|--------------------------------------------| | Common Name | Intramedullary Bone Fastener | | | Panel Code | Orthopaedics/87 | | | Classification Name | Smooth or threaded metallic bone fixation fastener | | | Class | Class II | | | Regulation Number | 21 CFR 888.3040 | | | Product Code | HTY | | | Name of Predicate Device | 510(k) # | Manufacturer | | ARROW-LOK Digital Fusion System | K112675 | Arrowhead Medical Device Technologies, LLC | | Description | | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The StarFuse Interphalangeal Pin is a fusion device available in a range
of profile diameters and lengths as well as straight or pre-bent options.
Implants are made from 316LVM Stainless Steel per ASTM F138 and
range in size from 3 to 4 mm in diameter and 16 to 30 mm in length. | | Indications and
Intended Use | StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes. | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Subject device, is
substantially equivalent to the Predicate ARROW-LOK Digital Fusion
System (K112675). The Subject device is substantially equivalent to the
predicate device in intended use, indications for use, materials,
technological characteristics, performance and labeling. | |--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data | Static and dynamic 3-point bending testing (per ASTM 1264-14)
confirmed that the Subject device performed as intended. | | Conclusion | Based on the intended use, indications for use, technological
characteristics, materials, and comparison to predicate device, the
Subject device has been shown to be substantially equivalent to legally
marketed predicate devices. | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K160194](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K160194) **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