← Product Code [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI) · K183618 # Revolution Radial Head (K183618) _Ignite Orthopedics, Inc. · KWI · May 17, 2019 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K183618 ## Device Facts - **Applicant:** Ignite Orthopedics, Inc. - **Product Code:** [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI.md) - **Decision Date:** May 17, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3170 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Ignite Orthopedics Revolution Radial Head is indicated for: - Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: o joint destruction and/or subluxation visible on x-ray; and/or o resistance to conservative treatment. - Primary replacement after fracture of the radial head. - Symptomatic sequelae after radial head resection. - Revision following failed radial head arthroplasty. ## Device Story Revolution Radial Head is a one-piece, stemmed radial head prosthesis used for elbow arthroplasty. Device replaces damaged radial head to restore joint function and alleviate pain. Implanted by orthopedic surgeons in clinical/surgical settings. System includes accessory instruments for site preparation and implant insertion. Device provides structural replacement for radio-humeral/proximal radio-ulnar joints. Benefits include improved joint mobility and pain reduction for patients with degenerative conditions or fractures. ## Clinical Evidence No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including bending stress analysis, endotoxin testing (LAL method), packaging integrity (ASTM D4169), accelerated aging (ASTM F1980-16), and sterilization validation (ISO 11137-1). ## Technological Characteristics One-piece stemmed radial head prosthesis; diameters 19-25mm; stems 5.5-8.5mm diameter, 21-24mm length. Material: wrought CoCrMo alloy (ASTM F1537). Sterilization: VDmax method (ISO 11137-1:2006/A1:2013) to SAL 10^-6. ## Regulatory Identification An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius. ## Predicate Devices - Wright Medical Evolve Modular Radial Head ([K060731](/device/K060731.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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Ignite Orthopedics, Inc. Russ Parrott VP of Research and Development 210 North Buffalo Street Warsaw, Indiana 46580 Re: K183618 Trade/Device Name: Revolution Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: December 21, 2018 Received: December 26, 2018 Dear Russ Parrott: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for May 17, 2019 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CAPT Raquel Peat, PhD, MPH, USPHS For: Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183618 Device Name Revolution Radial Head ## Indications for Use (Describe) The Ignite Orthopedics Revolution Radial Head is indicated for: - · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: - o joint destruction and/or subluxation visible on x-ray; and/or - o resistance to conservative treatment. - · Primary replacement after fracture of the radial head. - · Symptomatic sequelae after radial head resection. - Revision following failed radial head arthroplasty. 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 - K183618 | | |--------------------------|-------------------------------------------------------------------------------------------------------------| | Prepared: | December 21, 2018 | | Submitter: | Ignite Orthopedics, Inc.
210 North Buffalo Street
Warsaw, IN 46580 | | Contact: | Russ Parrott
VP of Research and Development
Phone: 574.527.2864
russ.parrott@igniteorthopedics.com | | Proprietary Name: | Revolution Radial Head | | Common Name: | Radial Head | | Classification: | 21 CFR §888.3170: Elbow joint radial (hemi elbow) polymer prosthesis;
Class II | | Product Code: | KWI | | Predicate Device: | Wright Medical Evolve Modular Radial Head, K060731 | ## Device Description: The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length. The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. {4}------------------------------------------------ ### Intended Use / Indications: The Ignite Orthopedics Revolution Radial Head is indicated for: - Replacement of the radial head for degenerative or post-traumatic disabilities presenting ● pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: - o joint destruction and/or subluxation visible on x-ray; and/or - resistance to conservative treatment. o - Primary replacement after fracture of the radial head. ● - Symptomatic sequelae after radial head resection. ● - Revision following failed radial head arthroplasty. ● ### Summary of Technologies/Substantial Equivalence: The Revolution Radial Head is substantially equivalent to the predicate devices in regards to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions. ### Non-Clinical Testing: Bending stress analysis was used to compare the strength of the Revolution Radial Heads with the strength of the predicate device. This analysis confirmed that the strength of the worst case Revolution Radial Head is greater than the strength of the worst case predicate device and is adequate for its intended use. Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of <20 EU/device. Packaging integrity testing met requirements per ASTM D4169 Distribution Cycle 13, Assurance Level 1. One Year accelerated aging was conducted according to ASTM F1980-16 to determine Package Shelf Life. Sterilization validations were completed using the VDmax method specified in ISO 11137-1:2006/A1:2013. The Sterility Assurance Level (SAL) is 10-6. ### Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Revolution Radial Head to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K183618](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K183618) **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