(68 days)
Not Found
No
The description mentions web-based software to assist the physician in creating an adjustment schedule, but it does not describe any features or capabilities that indicate the use of AI or ML for tasks like image analysis, predictive modeling, or automated decision-making. The software appears to be a tool for calculation and scheduling based on physician input.
Yes
The device is intended for limb lengthening, fracture fixation, and correction of deformities, all of which are considered therapeutic interventions.
No
Explanation: The device is described as a multilateral external fixation system intended for limb lengthening, fracture fixation, and correction of deformities. Its components facilitate physical manipulation and support, and the software component assists in creating an adjustment schedule, not in diagnosing a condition.
No
The device description explicitly lists multiple hardware components (rings, footplates, struts, instrumentation, implantable components) in addition to the web-based software. The performance studies also include mechanical testing of the hardware components.
Based on the provided information, the TL-HEX System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- TL-HEX System Function: The TL-HEX System is an external fixation system used for orthopedic procedures like limb lengthening, fracture fixation, and deformity correction. It is a mechanical device that is applied externally to the body to stabilize bones and facilitate healing or correction.
- Lack of Specimen Analysis: The description of the TL-HEX System and its intended use does not involve the analysis of any biological specimens. Its function is purely mechanical and structural.
Therefore, the TL-HEX System falls under the category of a surgical or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TL-HEX System is intended for limb lengthening by metaphyseal distractions, fixation of open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
Indications, both for adults and all pediatric subgroups except newborns, include:
- 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
- Pseudoarthrosis 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 non unions
Product codes
KTT, OSN
Device Description
The Subject device is a multilateral external fixation system. The System can also be used with a web-based software component that is designed to be used to assist the physician in creating a patient adjustment schedule that assists in adjusting the six struts.
Components of the System include:
Full, 5/8 and 3/8 aluminum Rings Double Row Footplates Adjustable struts Aluminum strut clips (number and direction) Stainless steel instrumentation such as hex drivers, wrenches, and pliers Implantable components such as half pins and wires Web-based software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and all pediatric subgroups except newborns
Intended User / Care Setting
Not Found
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)
The potential hazards have been evaluated and controlled through a Risk Management Plan.
All testing met or exceeded the requirements, as established by the test protocols and applicable standards. A review of the mechanical data indicates that the hardware components of the Subject device continues to be capable of withstanding expected loads without failure.
Additionally, software verification and validation testing were completed, in conformance with FDA's guidance document entitled "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The results indicate that the updated software continues to perform as intended.
The Subject device was therefore found to be substantially equivalent to the Predicate device.
Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following mechanical and software testing were performed:
• ASTM F1541-02 "Standard Specification and Test Methods for External Skeletal Fixation Devices"
• Software IQ, OQ, PQ
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC P O Box 15729 Wilmington, North Carolina 28408
May 10, 2017
Re: K170650
Trade/Device Name: Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: April 7, 2017 Received: April 11, 2017
Dear Cheryl Wagoner:
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. 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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
к170650
Device Name
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Indications for Use (Describe)
The TL-HEX System is intended for limb lengthening by metaphyseal distractions, fixation of open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
Indications, both for adults and all pediatric subgroups except newborns, include:
- · 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
- · Pseudoarthrosis 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 non unions
| 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) |
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3
Special 510(k) Premarket Notification Orthofix TrueLok Hexapod System (TL-HEX) V2.0
510(k) Summary
(as required by 21 CFR 807.92)
| Submitter | Orthofix Srl |
|---|---|
| Via delle Nazioni, 9 | |
| 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca Ricadona
Sr. Quality & Regulatory Affairs Manager |
|----------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| email | GianlucaRicadona@orthofix.it |
Date Prepared March 1, 2017
| Trade Name | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 |
|---|---|
| Common Name | Multilateral Fixators and Accessories |
| Panel Code | 87/ Orthopaedic |
| Classification | |
| Name | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | KTT, OSN |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | K152171 | Orthofix Srl |
| Description | The Subject device is a multilateral external fixation system. The System
can also be used with a web-based software component that is designed
to be used to assist the physician in creating a patient adjustment
schedule that assists in adjusting the six struts.
Components of the System include:
Full, 5/8 and 3/8 aluminum Rings Double Row Footplates Adjustable struts Aluminum strut clips (number and direction) Stainless steel instrumentation such as hex drivers, wrenches,
and pliers Implantable components such as half pins and wires Web-based software |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications and
Intended Use | The TL-HEX System is intended for limb lengthening by metaphyseal or
epiphyseal distractions, fixation of open and closed fractures, treatment of
non-union or pseudoarthrosis of long bones and correction of bony or soft
tissue defects or deformities. Indications, both for adults and all pediatric |
4
| subgroups except newborns, include but are not limited to: | |
|---|---|
| • 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 | |
| • Pseudoarthrosis 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 non-unions | |
| Technological | |
| Characteristics | |
| and Substantial | |
| Equivalence | Documentation was provided to demonstrate that the Subject device is |
| substantially equivalent to the Predicate Orthofix TL-HEX True Lok | |
| Hexapod System (TL-HEX) V1.4 (K152171). | |
| The subject device is substantially equivalent to the predicate device in | |
| intended use, indications for use, site of application, patient population, | |
| condition of use, technological characteristics, materials, mechanical | |
| performances and implantable components. | |
| The Subject device includes additional hardware components, minor | |
| changes to some existing ones and updated software version respect to | |
| the predicate. | |
| Performance Data | The potential hazards have been evaluated and controlled through a Risk |
| Management Plan. | |
| All testing met or exceeded the requirements, as established by the test | |
| protocols and applicable standards. A review of the mechanical data | |
| indicates that the hardware components of the Subject device continues | |
| to be capable of withstanding expected loads without failure. | |
| Additionally, software verification and validation testing were completed, | |
| in conformance with FDA's guidance document entitled "General | |
| Principles of Software Validation; Final Guidance for Industry and FDA | |
| Staff." The results indicate that the updated software continues to | |
| perform as intended. | |
| The Subject device was therefore found to be substantially equivalent to | |
| the Predicate device. | |
| Clinical data was not needed to support the safety and effectiveness of | |
| the Subject Device. | |
| The following mechanical and software testing were performed: | |
| • ASTM F1541-02 "Standard Specification and Test Methods for | |
| External Skeletal Fixation Devices" | |
| • Software IQ, OQ, PQ |
| Conclusion | Based upon similarities in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances and implantable components. Orthofix TrueLok Hexapod System (TL-HEX) V2.0 has been shown to be substantially equivalent to the legally marketed predicate device, and to be safe and effective for its intended use. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |