(55 days)
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
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
This document is a 510(k) Summary for the Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hardware Equivalence Test: The subject device hardware must be identical to the predicate device. | The subject device hardware is identical to the predicate device. |
| Risk Management Review: No new risks are introduced as a result of the modified indication. | It was determined through risk management that no new risks are introduced as a result of the modified indication. |
| Software Verification and Validation: Software performs as intended, conforming to FDA's guidance document "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." | Software verification and validation testing was completed in conformance with FDA's guidance. The results indicate that the software performs as intended. |
| Worst-Case Performance Equivalence: The subject device presents no new worst case for performance testing compared to the predicate. | The results demonstrated that the Subject device presents no new worst case for performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
As such, there is no mention of a clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The assessment relies on engineering and software validation data, and comparison to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical test set requiring ground truth established by experts was identified, this information is not applicable and not present in the document.
4. Adjudication Method for the Test Set
As there was no clinical test set, an adjudication method for ground truth is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device includes 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."
The document states, "Software verification and validation testing was completed... The results of software testing indicate that the software performs as intended." This suggests a standalone performance evaluation of the software components was conducted to ensure their functionality and accuracy in generating adjustment schedules. However, this is for the software component that assists a physician, not the entire physical system.
7. The Type of Ground Truth Used
For the hardware, the ground truth was the identity to the predicate device.
For the software, the ground truth was established by its demonstrated conformance to FDA's guidance for software validation and its intended performance. This implies that the software's outputs (e.g., patient adjustment schedules) were verified against expected or correct outputs, likely through internal validation standards and requirements.
8. The Sample Size for the Training Set
No training set is mentioned in the document because this K152171 pertains to demonstrating substantial equivalence for an updated version (V1.4) of an existing device (TL-HEX V1.3, K143125) and its software. The device is not learning or adaptive, so a traditional AI/ML training set is not applicable. The software's functionality is based on predefined algorithms for calculating adjustment schedules.
9. How the Ground Truth for the Training Set Was Established
As no training set was involved, this information is not applicable.
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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
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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
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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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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 RicadonaQuality & Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| 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 andaccessories |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | KTT, OSN |
| Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Orthofix TL-HEX True LokHexapod System (TL-HEX) V1.3 | K143125 | Orthofix Srl |
| Description | The Subject device is a multilateral external fixation system. The System canalso be used with a web-based software component that is designed to beused to assist the physician in creating a patient adjustment schedule thatassists 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 andIntended Use | The TL-HEX System is intended for limb lengthening by metaphyseal orepiphyseal distractions, fixation of open and closed fractures, treatment ofnon-union or pseudoarthrosis of long bones and correction of bony or softtissue defects or deformities. The TL-HEX System is intended for limblengthening by metaphyseal or epiphyseal distractions, fixation of open and |
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| closed fractures, treatment of non-union or pseudoarthrosis of long bonesand 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 ofmotion• Fractures and disease which generally may result in joint contractures orloss 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 | |
|---|---|
| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Orthofix TL-HEX TrueLok Hexapod System (TL-HEX) V1.4 is substantially equivalent to thepredicate Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.3 inintended use, operating principle, basic design, materials and components. |
| Performance Data | The subject device hardware is identical to the predicate device so additionaltesting of the hardware are not required. It was determined through riskmanagement that no new risks are introduced as a result of the modifiedindication.Software verification and validation testing was completed in conformancewith FDA's guidance document entitled “General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff." The results ofsoftware testing indicate that the software performs as intended. The resultsdemonstrated that the Subject device presents no new worst case forperformance testing. The Subject device was therefore found to besubstantially equivalent to the predicate.Clinical data was not needed to support the safety and effectiveness of theSubject Device. |
| Conclusion | Based on the comparison to predicate device, the Subject Orthofix TL-HEXTrue Lok Hexapod System (TL_HEX) V1.4 has been shown to be |
§ 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.