(130 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 that assists in adjusting the six struts." This suggests a rule-based or algorithmic approach to calculating adjustments, not necessarily AI/ML. There is no mention of AI, ML, or related terms, nor is there any description of training or test data sets which are typical for AI/ML-based devices.
Yes
The device is an external fixation system intended for limb lengthening, fracture fixation, and correction of deformities, all of which are considered therapeutic interventions.
No
The device is an external fixation system used for limb lengthening, fracture fixation, and correction of deformities. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (rings, 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, 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 the human body (limb lengthening, fracture fixation, deformity correction, etc.). This is a therapeutic and structural function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The components listed are all physical parts used in external fixation and surgical manipulation (rings, struts, pins, wires, instruments, and software to assist with adjustments). There are no components designed to analyze biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic measurements performed on samples taken from the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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. Within this range, indications 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 (comma separated list FDA assigned to the subject device)
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. The System can also be used with other existing Orthofix external fixation components and screws (such as TrueLok or X Caliber).
Components of the system include:
• Full and 5/8 aluminum Rings
• 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
Not Found
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 are capable of withstanding expected loads without failure. Additionally, 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 performed 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 Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device. The following mechanical and software testing were performed:
• ASTM F 1541-02 (2007) e1 "Standard Specification and Test Methods for External Skeletal Fixation Devices"
• ASTM F1541-01 Annex 7 "Test Method for External Skeletal Fixator-Bone Constructs"
• ASTM F543-07 Annex A2 "Test Method for Driving Torque of Metallic Bone Screws"
• Software IQ, OQ, PQ
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.
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.
Not Found
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
§ 888.3030 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2014
Orthofix Srl % Ms. Chervl Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408
Re: K141078 Trade/Device Name: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) 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: August 16, 2014 Received: August 18, 2014
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 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 vours.
Lori A. Wiggins -S
for 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): K141078 (pg 1/1)
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) Device Name:
Indications for Use:
The TL-HEX System is intended for limb lengthening by metaphyseal or epiphyseal distractions, fixation of open and closed fractures, treatment of nonunion or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. Within this range, indications 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
Prescription Use ________________________________________(21 CFR 801 Subpart (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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 |
Date Prepared April 17, 2014
| Trade Name | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) |
|---|---|
| Common Name | Multilateral Fixators and Accessories |
| Panel Code | Orthopaedics/87 |
| 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 |
|---|---|---|
| Smith & Nephew Inc, Circular | ||
| Spatial Frame | K093047 | Smith and Nephew |
| True/Lok Monolateral/Bilateral | ||
| Fixator | K941048 | Orthofix (originally submitted by Applied |
| Osteo Systems, Inc.) | ||
| Orthofix Modulsystem (XCaliber) | K955848 | Orthofix |
| 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. The System can also be
used with other existing Orthofix external fixation components and screws
(such as TrueLok or X Caliber). |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Components of the system include:
• Full and 5/8 aluminum Rings
• 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. Within this range, indications 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) is substantially equivalent to the
Predicates Smith & Nephew Inc, Circular Spatial Frame (K093047),
True/Lok Monolateral/Bilateral Fixator (K941048), and Orthofix
Modulsystem (K955848). The TL-HEX System is substantially equivalent
to the predicate devices in intended use, indications for use, technological
characteristics, and labeling. |
| 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 are capable
of withstanding expected loads without failure. Additionally, 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 performed 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 Predicates. Clinical data was not needed
to support the safety and effectiveness of the Subject Device.
The following mechanical and software testing were performed:
• ASTM F 1541-02 (2007) e1 "Standard Specification and Test
Methods for External Skeletal Fixation Devices"
• ASTM F1541-01 Annex 7 "Test Method for External Skeletal Fixator-
Bone Constructs"
• ASTM F543-07 Annex A2 "Test Method for Driving Torque of
Metallic Bone Screws"
• Software IQ, OQ, PQ |
| Conclusion | Based on the indications for use, technological characteristics, materials,
and comparison to predicate devices, the Subject Orthofix TL-HEX True
Lok Hexapod System (TL_HEX) has been shown to be substantially |
4
for its intended use.