← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K231343 # Redemption Duo Hindfoot Nail System (K231343) _Vilex, LLC · HSB · Jan 30, 2024 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K231343 ## Device Facts - **Applicant:** Vilex, LLC - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Jan 30, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion) Specific indications include: - Post-traumatic or degenerative arthritis - Previously infected arthrosis - Revision ankle arthrodesis - Failed total ankle arthroplasty - Avascular necrosis of the talus - Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease - Rheumatoid arthritis - Osteoarthritis - Pseudarthrosis - Trauma (malunited tibial pilon fracture) - Charcot foot - Severe endstage degenerative arthritis - Severe defects after tumor resection - Pantalar arthrodesis - Post-traumatic arthrosis - Neuroarthropathy ## Device Story The Vilex Redemption Duo Hindfoot Nail System is an orthopedic implant system used for tibiotalocalcaneal arthrodesis. The system comprises intramedullary nails, endcaps, and locking screws. It is implanted into the talocrural region by orthopedic surgeons to stabilize the joint and facilitate bone fusion. The device is provided non-sterile and requires sterilization by the healthcare facility prior to surgery. It is used in an operating room setting. The system includes specific instrumentation for site preparation, implantation, and removal. By providing rigid internal fixation, the device maintains bone alignment, promoting fusion and potentially alleviating pain and restoring function in patients with severe foot and ankle pathology. ## Clinical Evidence Bench testing only. Performance data included bending fatigue (ASTM F1264-16e1), static and dynamic four-point bending (ASTM F1264-16e1), static torsion (ASTM F543-17, ASTM F1264-16e1), driving torque (ASTM F543-17), removal torque (ASTM F543-17), and axial pullout strength (ASTM F543-17). ## Technological Characteristics Materials: Titanium alloy (Ti-6Al-4V ELI per ASTM F136) and PEEK (ASTM F2026). Components: Intramedullary nails, endcaps, locking screws. Principle: Intramedullary fixation for arthrodesis. Sterilization: Provided non-sterile; requires facility-based sterilization. Connectivity: None (mechanical implant). ## Regulatory Identification An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. ## Predicate Devices - Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail ([K091976](/device/K091976.md)) ## Reference Devices - Arthrex DualCompression Hindfoot Fusion Nail Implant System ([K221031](/device/K221031.md)) - Synthes Hindfoot Arthrodesis Nail System ([K051678](/device/K051678.md)) - TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System ([K173811](/device/K173811.md)) - FUZE: Intramedullary Internal Fixation Nail ([K102413](/device/K102413.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}------------------------------------------------ January 30, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with a stylized image of a human figure. To the right of the seal, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font and is placed inside a blue square. Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110 Re: K231343 Trade/Device Name: Redemption Duo Hindfoot Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 21, 2023 Received: December 21, 2023 Dear Brock Johnson: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. 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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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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Russell -S Date: 2024.01.30 10:26:04 -05'00' for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K231343 #### Device Name Vilex Redemption Duo Hindfoot Nail System Indications for Use (Describe) The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion) Specific indications include: - · Post-traumatic or degenerative arthritis - · Previously infected arthrosis - · Revision ankle arthrodesis - Failed total ankle arthroplasty - · Avascular necrosis of the talus - · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease - Rheumatoid arthritis - · Osteoarthritis - Pseudarthrosis - · Trauma (malunited tibial pilon fracture) - · Charcot foot - · Severe endstage degenerative arthritis - Severe defects after tumor resection - Pantalar arthrodesis - · Post-traumatic arthrosis - · Neuroarthropathy | 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 # I. Submitter Vilex LLC 111 Moffitt Street McMinnville, TN 37110 Contact Person: Brock Johnson, President of Vilex Phone: (801) 916-4157 brock.johnson@vilex.com Date Prepared: 20 April 2023 ## II. Device | Device Proprietary Name: | Redemption Duo Hindfoot Nail System | |--------------------------|-----------------------------------------------| | Common or Usual Name: | Rod, Fixation, Intramedullary and Accessories | | Classification Name: | Intramedullary Fixation Rod | | Regulation Number: | 21 CFR 888.3020 | | Product Code: | HSB | | Device Classification | II | ## III. Predicate Device Substantial equivalence is claimed to the following devices: | Device
Type | 510(k)
Number | Trade Name | Applicant | Product
Code | |----------------------|------------------|----------------------------------------------------------------|------------------|-----------------| | Subject
Device | - | Redemption Duo Hindfoot Nail System | Vilex | HSB | | Primary
Predicate | K091976 | Biomet Phoenix Ankle Nail and Ankle
Arthrodesis Nail | Zimmer
Biomet | HSB | | Reference
Device | K221031 | Arthrex DualCompression Hindfoot
Fusion Nail Implant System | Arthrex | HSB | | Reference
Device | K051678 | Synthes Hindfoot Arthrodesis Nail
System | Depuy
Synthes | HSB | | Reference
Device | K173811 | TRIWAY Tibiotalocalcaneal (TTC)
Arthrodesis System | In2Bones
SAS | HSB
HWC | | Reference
Device | K102413 | FUZE: Intramedullary Internal Fixation
Nail | Vilex | HSB | # IV. Device Description The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are {4}------------------------------------------------ packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery. ## V. Indications for Use The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion) Specific indications include: - Post-traumatic or degenerative arthritis . - Previously infected arthrosis ● - Revision ankle arthrodesis . - Failed total ankle arthroplasty . - . Avascular necrosis of the talus - Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease - Rheumatoid arthritis . - . Osteoarthritis - Pseudarthrosis . - Trauma (malunited tibial pilon fracture) . - Charcot foot ● - Severe endstage degenerative arthritis . - Severe defects after tumor resection . - Pantalar arthrodesis ● - Post-traumatic arthrosis ● - Neuroarthropathy . # VI. Comparison of Technological Characteristics with the Predicate Devices The subject and predicate devices have similar intended uses and share identical core characteristics. The subject and predicate devices are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). At a high level, the subject and predicate devices share the following technological characteristics: - Product code - Indications for Use - Principles of Operation ● - Material of construction ● - Nail lengths ● - Nail diameters ● - Cap lengths - Screw lengths - Screw diameter ● - Sterilization method The technological differences between the subject device and predicate devices include minor dimensional differences and differences in raw material and sterilization method. These changes are {5}------------------------------------------------ considered minor and do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below. ### VII. Performance Data The following performance data were provided in support of the substantial equivalence determination: - Bending Fatigue per ASTM F1264-16e1 ● - Static Torsion per ASTM F543-17 - Driving Torque per ASTM F543-17 - Removal Torque per ASTM F543-17 - Axial Pullout Strength per ASTM F543-17 ● - Static Four-Point Bending per ASTM F1264-16e1 ● - Static Torsion per ASTM F1264-16e1 - Dynamic Four-Point Bending per ASTM F1264-16e1 ● ## VIII. Conclusion The information provided above supports that the Vilex Redemption Duo Hindfoot Nail System is as safe and effective as the predicate device. Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K231343](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K231343) **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