SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

K190069 · Arrowhead De, LLC · KTT · May 14, 2019 · Orthopedic

Device Facts

• Record ID: K190069
• Device Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
• Applicant: Arrowhead De, LLC
• Product Code: KTT · Orthopedic
• Decision Date: May 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

Device Story

SixFix™ Hexapod Fixator is a multilateral circular external fixation system comprising rings, footplates, arches, struts, threaded rods, and wires. System treats bone deformities and fractures by adjusting strut lengths to alter ring orientation, thereby manipulating bone segments connected via half-pins and wires. DACS is an optional software component used by physicians to calculate required strut lengths for desired bone translation/rotation. Physician inputs parameters into software; software computes necessary adjustments and visualizes bone position. Used in clinical settings to assist surgeons in planning and implementing orthopedic corrections. Benefits include precise, gradual bone manipulation to achieve treatment goals for complex orthopedic conditions.

Clinical Evidence

No clinical data. Evidence consists of static and dynamic mechanical bench testing and software verification/validation testing. Software documentation provided for Moderate Level of Concern, including hazard analysis, requirements, design specifications, and cybersecurity risk analysis.

Technological Characteristics

Multilateral circular external fixation system. Components: rings, footplates, arches, struts, threaded rods, wires. Materials: metallic. Software: DACS for deformity analysis and strut length calculation. Connectivity: not specified. Sterilization: provided non-sterile, single use. Software class: Moderate Level of Concern.

Indications for Use

Indicated for patients requiring treatment for post-traumatic joint contracture, fractures, pseudo-arthrosis of long bones, limb lengthening, bony or soft tissue deformities/defects, joint arthrodesis, or infected fractures/nonunions.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Taylor Spatial Frame (K093047, K970748)
• Deformity Analysis and Correction Software (DASC) and Instrumentation (K180539)
• Ilizarov External Fixation Wires (K870961, K962808)

Submission Summary (Full Text)

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July 5, 2022

Arrowhead DE, LLC Patrick Mullaney President/CEO 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017

Re: K190069

Trade/Device Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HTY, OSN

Dear Patrick Mullaney:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 14, 2019. Specifically, FDA is updating this SE Letter to address the inconsistent indications for use in the FDA Form 3881 as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ting Song, Ph.D., OHT6: Office of Orthopedic Devices, 301-796-7677, [e-mail].

Sincerely,

Ting Song -S

Ting Song, Ph.D. 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

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 14, 2019

Arrowhead DE, LLC Patrick Mullaney President/CEO 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017

Re: K190069

Trade/Device Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT, HTY, OSN Dated: April 17, 2019 Received: April 18, 2019

Dear Patrick Mullaney:

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/cfpm/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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

Digitally signed by Peter G. Peter G. Allen -S Date: 2019.05.14 Allen -S 10:08:37 -04'00'

FOR CAPT Raquel Peat, PhD, MPH, USPHS 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

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# Indications for Use

510(k) Number (if known) K190069

#### Device Name

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

#### Indications for Use (Describe)

The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for posttraumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

Type of Use (Select one or both, as applicable):

| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------|
| <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary SixFix™ Hexapod Fixator and DACS K190069

## l. Submitter:

Arrowhead Medical Device Technologies, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017

Contact Person: Thomas J. Twardzik Vice President, Marketing and Operations Office: [phone] Fax: [phone] Email: [e-mail]

Date of Summary: May 7, 2019

## II: Device

Proprietary Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Common Name: Orthopaedic Software for Treatment and Instrumentation Regulatory Class: Class II

Regulation:

21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories

21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener Device Product Codes: KTT, HTY, and OSN Panel: Orthopedic

| III. Predicate Devices | |
|------------------------|--|
|------------------------|--|

| Device | Manufacturer | 510(k) No. | Clearance<br>Date |
|--------------------------------------------------------------------------------|--------------------------------------------------|------------|-------------------|
| Primary Predicate | | | |
| Taylor Spatial Frame | Smith & Nephew | K093047 | 09/27/2010 |
| | | K970748 | 05/09/1997 |
| Secondary Predicates | | | |
| Deformity Analysis and<br>Correction Software<br>(DASC) and<br>Instrumentation | Arrowhead Medical<br>Device<br>Technologies, LLC | K180539 | 08/13/2018 |
| Ilizarov External<br>Fixation Wires | Smith & Nephew | K870961 | 03/19/1987 |
| | | K962808 | 08/19/1996 |

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## 510(k) Summary SixFix™ Hexapod Fixator and DACS K190069

## IV. Device Description

The SixFix™ Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.

The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient's treatment goals.

The Deformity Analysis and Correction Software is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon.

## V. Intended Use

The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

## VI. Comparison of Technological Characteristics with the Predicate Devices

The SixFix™ Hexapod Fixator is technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. Testing and analyses confirmed that the Hexapod™ Fixator is substantially equivalent when compared to the predicate device. The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

The subject device and predicate devices are optional software programs that are used with a spatial frame external fixation system. The functions performed by the SixFix™ DACS match the functions performed by the predicate DACS (K180539). Software validation confirmed that the DACS should perform as intended.

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## 510(k) Summary SixFix™ Hexapod Fixator and DACS K190069

### VII. Performance Data

Static and dynamic mechanical testing were performed in support of the submission. The testing confirmed that the subject SixFix™ Hexapod Fixator is substantially equivalent to the predicate device.

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a Moderate Level of Concern. Documentation for Moderate Level of Concern was provided as follows.

- Device Hazard Analysis
- Software Requirements Specification ●
- Architectural Design Charts
- Software Design Specification Traceability Analysis
- Software Development Environment Description
- Software Verification Plan and Protocol
- Variety Testing Software Verification Protocol
- Cybersecurity Risk Analysis Report
- Off-the-Shelf Software Analysis
- Software Release Record
- Unresolved Anomaly Report
- Verification and Validation Documentation

From the evidence submitted in this 510(k) for the software, the Deformity Analysis and Correction Software (DACS) demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates. The design characteristics of the subject system software do not raise any new types of questions of safety or effectiveness.

## VIII. Conclusions

A review of the device indications, material composition, external element design, and technological characteristics confirmed that the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software are substantially equivalent to the predicate device. While the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software are not identical to the predicate device, comparisons of the subject and predicate device confirmed that any differences between the subject device and predicate do not render the device NSE as there is not a new intended use; and any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software is substantially equivalent to the predicate devices.