K Number
K221031
Device Name
Arthrex DualCompression Hindfoot Fusion Nail Implant System
Manufacturer
Date Cleared
2022-12-20

(257 days)

Product Code
Regulation Number
888.3020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
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.
More Information

No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant system, with no mention of AI or ML technology.

Yes

The device is an implant system intended to facilitate tibiotalcaneal arthrodesis to treat various severe foot/ankle conditions, which directly addresses a medical condition.

No
The device is described as an implant system ("The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprised of the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cable and End Caps.") used for arthrodesis and to treat various conditions, which is a therapeutic rather than a diagnostic function.

No

The device description explicitly details physical components made of titanium, nitinol, and PEEK, which are hardware implants. There is no mention of software as a component of the device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is an implant system designed to facilitate surgical procedures (tibiotalcaneal arthrodesis) to treat various conditions of the foot and ankle. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
  • Device Description: The description details the physical components of the implant (nails, screws, end caps) and the materials they are made from. This aligns with a surgical implant, not a diagnostic device.
  • Performance Studies: The performance studies described focus on the mechanical properties, biocompatibility, and safety of the implant within the body (e.g., bending, torque, fatigue, corrosion, MRI compatibility, biological response). These are relevant to a surgical implant, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.

In summary, the Arthrex DualCompression Hindfoot Fusion Nail Implant System is a surgical implant intended for therapeutic use, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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 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.

Product codes (comma separated list FDA assigned to the subject device)

HSB

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hindfoot, tibiotalocalcaneal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 , USP , 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.

Key results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090857: Wright Medical VALOR Ankle Fusion Nail System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3020 Intramedullary fixation rod.

(a)
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.(b)
Classification. Class II.

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

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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)

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510(k) Summary

Date PreparedDecember 19, 2022
SubmitterArthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945
Contact PersonRebecca R. Homan
Team Lead, Regulatory Affairs – Product Development
1-239-643-5553, ext. 73429
rebecca.homan@arthrex.com
Name of DeviceArthrex DualCompression Hindfoot Fusion Nail Implant System
Common NameRod, Fixation, Intramedullary And Accessories
Product CodeHSB
Classification Name21 CFR 888.3020: Intramedullary fixation rod
Regulatory ClassII
Predicate DeviceK090857: Wright Medical VALOR Ankle Fusion Nail System
Reference DeviceK142602: Wright Medical VALOR Hindfoot Fusion Nail System
K171376: Medshape Solutions DynaNail TTC Fusion System
K113828: Medshape Solutions DynaNail Ankle Arthrodesis Nail
Purpose of SubmissionThis Traditional 510(k) premarket notification is submitted to obtain clearance for
the Arthrex DualCompression Hindfoot Fusion Nail Implant System.
Device DescriptionThe 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 , USP , 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. |