Who is the manufacturer of Arthrex DualCompression Hindfoot Fusion Nail Implant System?

Arthrex, Inc. filed the 510(k) submission for Arthrex DualCompression Hindfoot Fusion Nail Implant System (K221031).

What is the FDA product code for Arthrex DualCompression Hindfoot Fusion Nail Implant System?

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Arthrex DualCompression Hindfoot Fusion Nail Implant System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Arthrex DualCompression Hindfoot Fusion Nail Implant System?

Wright Medical VALOR Ankle Fusion Nail System (K090857).

Who can help prepare an FDA 510(k) submission like Arthrex DualCompression Hindfoot Fusion Nail Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arthrex DualCompression Hindfoot Fusion Nail Implant System

K221031 · Arthrex, Inc. · HSB · Dec 20, 2022 · Orthopedic

Device Facts

Record ID	K221031
Device Name	Arthrex DualCompression Hindfoot Fusion Nail Implant System
Applicant	Arthrex, Inc.
Product Code	HSB · Orthopedic
Decision Date	Dec 20, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended to facilitate tibiotalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include neuro-osteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.

Device Story

System facilitates tibiotalcaneal arthrodesis; consists of intramedullary nails, interlocking screws, cable, and end caps. Nails implanted into intramedullary canal to stabilize joint; screws provide fixation. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical stability to promote bone fusion; benefits patients by correcting deformity and alleviating pain from severe foot/ankle conditions. System components manufactured from titanium alloy, nitinol, PEEK, and stainless steel. Device is single-use; nails provided sterile, screws/caps non-sterile.

Clinical Evidence

Bench testing only. No clinical data. Testing included static four-point bend, static/dynamic torque, dynamic compression bending fatigue, fatigue strength, static/dynamic 3-point bend (ASTM F1264-16e1), axial pull-out, maximum torque, breaking angle (ASTM F543-17), corrosion resistance (ASTM F2129), fretting corrosion (ASTM F1875, F897), ion release (ASTM F3306), and bend/free recovery (ASTM F2082). Biocompatibility testing per ISO 10993-1:2018. MRI safety testing performed per FDA guidance and relevant ASTM standards.

Technological Characteristics

Intramedullary fixation rod system. Materials: Titanium Alloy (ASTM F136), Superelastic Nitinol (ASTM F2063), PEEK (ASTM F2026), Stainless Steel (ASTM F138). Components: Nails (10.5-12.5mm diameter, 180-300mm length), 5.0mm diameter interlocking screws, end caps, cable. Mechanical fixation via intramedullary rod and screws. MR Conditional.

Indications for Use

Indicated for patients requiring tibiotalcaneal arthrodesis due to severe foot/ankle deformity, arthritis, instability, skeletal defects post-tumor resection, Charcot's foot, talar avascular necrosis, failed joint replacement/fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, or pseudoarthrosis.

Regulatory Classification

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

Wright Medical VALOR Ankle Fusion Nail System (K090857)

Reference Devices

Wright Medical VALOR Hindfoot Fusion Nail System (K142602)
Medshape Solutions DynaNail TTC Fusion System (K171376)
Medshape Solutions DynaNail Ankle Arthrodesis Nail (K113828)

Related Devices

K141571 — ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM · Orthofix Srl · Nov 12, 2014
K201227 — Phantom® Hindfoot TTC/TC Nail System · Paragon 28, Inc. · Jul 17, 2020
K163589 — SIGN IM Nail · Sign Fracture Care International · Jul 20, 2017
K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) · Small Bone Innovations, Inc. · May 3, 2013
K192163 — TTC Phantom® Intramedullary Nail System · Paragon 28, Inc. · Jan 31, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". December 20, 2022 Arthrex Inc. Rebecca Homan Team Lead, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K221031 Trade/Device Name: Arthrex DualCompression Hindfoot Fusion Nail Implant System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 30, 2022 Received: November 30, 2022 Dear Rebecca Homan: 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 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 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 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). Sincerely, Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Victoria A. Lilling -S. The date of the signature is 2022.12.20. The time of the signature is 15:31:51 -05'00'. Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K221031 Device Name Arthrex DualCompression Hindfoot Fusion Nail Implant System Indications for Use (Describe) The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended to facilitate tibiotalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after turnor resection. These include neuroosteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis. | 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 | Date Prepared | December 19, 2022 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 | | Contact Person | Rebecca R. Homan Team Lead, Regulatory Affairs – Product Development 1-239-643-5553, ext. 73429 rebecca.homan@arthrex.com | | Name of Device | Arthrex DualCompression Hindfoot Fusion Nail Implant System | | Common Name | Rod, Fixation, Intramedullary And Accessories | | Product Code | HSB | | Classification Name | 21 CFR 888.3020: Intramedullary fixation rod | | Regulatory Class | II | | Predicate Device | K090857: Wright Medical VALOR Ankle Fusion Nail System | | Reference Device | K142602: Wright Medical VALOR Hindfoot Fusion Nail System K171376: Medshape Solutions DynaNail TTC Fusion System K113828: Medshape Solutions DynaNail Ankle Arthrodesis Nail | | Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex DualCompression Hindfoot Fusion Nail Implant System. | | Device Description | The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprised of the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cable and End Caps. The Arthrex DualCompression Hindfoot Nail is available in 10.5, 11.5 and 12.5 mm diameters and lengths of 180, 210, 240 and 300 mm. The Interlocking Screws are fully threaded, headed or headless, self-tapping, solid, low profile screws. The screw family is 5.0 mm in diameter and ranges from 20 mm to 120 mm in length (in 2 or 5 mm increments). The End Caps are designed to prevent bone in growth in the distal portion of the Nail implant for ease of removal. The end cap family ranges from 1 to 11 mm in length for various countersinking depths. The Arthrex DualCompression Hindfoot Fusion Nails are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136), Superelastic Nitinol (conforming to ASTM F2063) and Polyetheretherketone (PEEK)(conforming to ASTM F2026). The Arthrex DualCompression Hindfoot Nail is sold sterile and is single-use. The Interlocking Screws and End Caps are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136). The Interlocking Screws and End Caps are sold non-sterile and are single-use. | | Indications for Use | The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include neuro-osteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis. | | Performance Data | Static four-point bend, static torque, dynamic compression bending fatigue, fatigue strength, static and dynamic 3-point bend (ASTM F1264-16e1), axial pull- out, maximum torque, and breaking angle (ASTM F543-17) testing was conducted to demonstrate that the Arthrex DualCompression Hindfoot Fusion Nail Implant System performs equivalent to the predicate devices cleared under K090857. | | | | | | Corrosion resistance (ASTM F2129), fretting corrosion (ASTM F1875, ATM F897) and bend and free recovery (ASTM F2082/F2082M) testing was conducted on the Arthrex DualCompression Hindfoot Fusion Nail Implant System. An in-vitro fretting corrosion (ASTM F1875) and ion release (ASTM F3306) study was conducted on the Arthrex DualCompression Hindfoot Fusion Nail Implant System. Arthrex preformed engineering analyses to conclude that the insertion torque, failure torque, driving torque and removal torque values of the Arthrex | | | DualCompression Hindfoot Fusion Nail Implant System were acceptable. MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. | | | Bacterial Endotoxins Test (BET) was performed on the Arthrex DualCompression Hindfoot Fusion Nail Implant System utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex DualCompression Hindfoot Fusion Nail Implant System meet pyrogen limit specifications. | | | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the devices within the Arthrex DualCompression Hindfoot Fusion Nail Implant System in accordance with ISO 10993-1:2018. | | | Assessment of physical product attributes including product, design, size, and materials has determined that the Arthrex DualCompression Hindfoot Fusion Nail Implant System does not introduce additional risks or concerns regarding sterilization and shelf-life. | | Technological Comparison | The Arthrex DualCompression Hindfoot Fusion Nail Implant System is substantially equivalent to the primary predicate devices cleared under K090857; and reference devices cleared under K142602, K171376 and K113828 in which the basic design features, intended use and fundamental scientific technology are identical. | | | The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprised of the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cable and End Caps. | | | The Arthrex DualCompression Hindfoot Nail is available in 10.5, 11.5 and 12.5 mm proximal diameters (with a 12.5 mm distal diameter) and lengths of 180, 210, 240 and 300 mm. The Arthrex DualCompression Hindfoot Fusion Nails are manufactured from | {4}------------------------------------------------ {5}------------------------------------------------ Titanium Alloy (Ti-6AL-4V conforming to ASTM F136), Superelastic Nitinol (conforming to ASTM F2063) and Polyetheretherketone (PEEK)(conforming to ASTM F2026). The Arthrex DualCompression Hindfoot Fusion Nails are sold sterile and are single-use. ● The Interlocking Screws are fully threaded, headed or headless selftapping solid low profile screws. The headed and headless screw family is 5.0 mm in diameter and ranges from 20 mm to 120 mm in length (in 2 or 5 mm increments). The End Cap family ranges from 1 to 11 mm in length for various countersinking depths The Interlocking Screws and End Caps are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136). The Interlocking Screws and End Caps are sold non-sterile and are single-use. . The Arthrex DualCompression Hindfoot Fusion Cable is manufactured from Stainless Steel (conforming to ASTM F138). The Arthrex DualCompression Hindfoot Fusion Cable is sold sterile and is single-use. The primary predicate device Wright Medical VALOR Ankle Fusion Nail System, K930834 is comprised of the Wright Medical VALOR Ankle Fusion Nails and screws. The nails were cleared in 10.0 and 11.5 proximal diameters (with a 12.5 mm distal diameter) and lengths of 150, 200 and 250 mm. The screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 100 mm. The nails and screws are manufactured from Titanium Alloy. The nails and screws are single-use. The reference device Wright Medical VALOR Hindfoot Fusion Nail System. K142602 is comprised of the Wright Medical VALOR Hindfoot Fusion Nails and screws. The nails were cleared in 10.0 and 11.5 proximal diameters (with a 12.0 mm distal diameter) and length of 300 mm. The screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 120 mm. The nails and screws are manufactured from Titanium Alloy. The nails and screws are single-use. The reference device Medshape Solutions DynaNail TTC Fusion System, K171376 is comprised of the Medshape Solutions DynaNail TTC Fusion Nails and screws. The nails were cleared in 10, 11 and 12 mm proximal diameters (with a 12.5 mm distal diameter) and length of 180, 220, 260, and 300 mm. The headed and headless screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 110 mm. The nails are manufactured from Titanium Alloy and Nitinol. The screws are manufactured from Titanium Alloy. The nails and screws are single-use. The reference device Medshape Solutions DynaNail Ankle Arthrodesis Nail, K113828 is comprised of the Medshape Solutions DynaNail Ankle Arthrodesis Nails and screws. The nails were cleared in 10, 11 and 12 mm proximal diameters (with a 12.5 mm distal diameter) and length of 180, 220, 260, and 300 mm. The headed and headless screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 110 mm. The nails are manufactured from Titanium Alloy and Nitinol. The screws are manufactured from Titanium Alloy. The nails and screws are single-use. {6}------------------------------------------------ | | The Arthrex DualCompression Hindfoot Fusion Nail Implant System was evaluated for MR Conditional labeling, while the MRI Safety of primary predicate devices cleared under K090857 and reference devices cleared under K142602, K171376 and K113828 is unknown. | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Arthrex DualCompression Hindfoot Fusion Nail Implant System is substantially equivalent to the primary predicate devices cleared under K090857; and reference devices cleared under K142602, K171376 and K113828, with minor dimensional modifications with no change to intended use or function. Any differences between the Arthrex DualCompression Hindfoot Fusion Nail Implant System and the predicate devices are considered minor and do not raise different questions of safety or effectiveness. | | Conclusion | The Arthrex DualCompression Hindfoot Fusion Nail Implant System is substantially equivalent to the predicate devices cleared under K090857, K142602, K171376 and K113828; in which the basic design features and intended use are the same. Any differences between the Arthrex DualCompression Hindfoot Fusion Nail Implant System and the predicate devices are considered minor and do not raise different questions of safety or effectiveness. | | | The submitted mechanical testing data demonstrates that the static four-point bend, static torque, dynamic compression bending fatigue, fatigue strength, static and dynamic 3-point bend and axial pull-out strength of the Arthrex DualCompression Hindfoot Fusion Nail Implant System is substantially equivalent to that of the predicate devices for the desired indications. | | | Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate devices. |