(55 days)
Not Found
No
The description mentions a "web-based software component that is designed to be used to assist the physician in creating a patient adjustment schedule," but there is no mention of AI or ML algorithms being used for this assistance. The software validation focuses on general software principles, not AI/ML specific testing.
Yes
The device is used for treatment of injuries and deformities such as fractures, non-union or pseudoarthrosis of long bones, limb lengthening, and correction of bony or soft tissue defects or deformities.
No
The device description and intended use indicate that the TL-HEX System is an external fixation system used for various orthopedic procedures like limb lengthening and fracture fixation, not for diagnosing medical conditions. While it has a software component to assist physicians in creating an adjustment schedule, its primary function is therapeutic.
No
The device is described as a "multilateral external fixation system" with various hardware components listed (rings, footplates, struts, instrumentation, pins, wires). While it includes a web-based software component, the core device is a physical external fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on long bones (limb lengthening, fracture fixation, deformity correction, etc.). This is a therapeutic and structural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The components listed are all related to an external fixation system used in surgery (rings, struts, pins, wires, instrumentation). The software component assists in adjusting the device, not in analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status based on in vitro analysis.
Therefore, the TL-HEX System is a surgical 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. 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
Long bones
Indicated Patient Age Range
adults and all pediatric subgroups except newborns
Intended User / Care Setting
Physician (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)
The subject device hardware is identical to the predicate device so additional testing of the hardware are not required. It was determined through risk management that no new risks are introduced as a result of the modified indication.
Software verification and validation testing was completed in conformance with FDA's guidance document entitled “General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The results of software testing indicate that the software performs as intended. The results demonstrated that the Subject device presents no new worst case for performance testing. The Subject device was therefore found to be substantially equivalent to the predicate.
Clinical data was not needed to support the safety and effectiveness of the Subject Device.
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
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2015
Orthofix Srl % Cheryl Wagoner Principal Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408
Re: K152171
Trade/Device Name: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 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: July 31, 2015 Received: August 4, 2015
Dear Ms. 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
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) K152171
Device Name
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
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. 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
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
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.com |
September 28, 2015 Date Prepared
| Trade Name | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 |
|---|---|
| Common Name | Multilateral Fixators and Accessories |
| Panel Code | 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 |
| Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Orthofix TL-HEX True Lok | ||
| Hexapod System (TL-HEX) V1.3 | K143125 | 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. The TL-HEX System is intended for limb
lengthening by metaphyseal or epiphyseal distractions, fixation of open and |
4
| 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 | |
|---|---|
| Technological | |
| Characteristics | |
| and Substantial | |
| Equivalence | Documentation was provided to demonstrate that the Orthofix TL-HEX True |
| Lok Hexapod System (TL-HEX) V1.4 is substantially equivalent to the | |
| predicate Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.3 in | |
| intended use, operating principle, basic design, materials and components. | |
| Performance Data | The subject device hardware is identical to the predicate device so additional |
| testing of the hardware are not required. It was determined through risk | |
| management that no new risks are introduced as a result of the modified | |
| indication. |
Software verification and validation testing was completed in conformance
with FDA's guidance document entitled “General Principles of Software
Validation; Final Guidance for Industry and FDA Staff." The results of
software testing indicate that the software performs as intended. The results
demonstrated that the Subject device presents no new worst case for
performance testing. The Subject device was therefore found to be
substantially equivalent to the predicate.
Clinical data was not needed to support the safety and effectiveness of the
Subject Device. |
| Conclusion | Based on the comparison to predicate device, the Subject Orthofix TL-HEX
True Lok Hexapod System (TL_HEX) V1.4 has been shown to be |