ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)

K141078 · Orthofix Srl · KTT · Sep 2, 2014 · Orthopedic

Device Facts

• Record ID: K141078
• Device Name: ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
• Applicant: Orthofix Srl
• Product Code: KTT · Orthopedic
• Decision Date: Sep 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Multilateral external fixation system for orthopedic limb reconstruction; comprises aluminum rings, adjustable struts, and stainless steel instrumentation (pins/wires). Used by physicians to stabilize fractures or correct deformities. Includes web-based software to assist physicians in calculating patient-specific strut adjustment schedules. Physician inputs clinical parameters into software; software generates adjustment plan; physician uses plan to manually adjust struts over time. Facilitates controlled bone distraction or deformity correction; improves patient outcomes by enabling precise, gradual skeletal alignment.

Clinical Evidence

No clinical data. Bench testing only. Mechanical testing performed per ASTM F1541-02, ASTM F1541-01 Annex 7, and ASTM F543-07. Software verification and validation (IQ, OQ, PQ) performed per FDA guidance.

Technological Characteristics

Multilateral external fixation system. Materials: Aluminum (rings, struts), stainless steel (instrumentation, pins, wires). Connectivity: Web-based software for adjustment scheduling. Testing standards: ASTM F1541-02, ASTM F1541-01 Annex 7, ASTM F543-07.

Indications for Use

Indicated for patients requiring limb lengthening, fracture fixation (open/closed), treatment of nonunion/pseudoarthrosis, correction of bony/soft tissue deformities/defects, joint arthrodesis, or treatment of infected fractures/non-unions, including those with post-traumatic joint contracture or loss of range of motion.

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

• Smith & Nephew Inc, Circular Spatial Frame (K093047)
• True/Lok Monolateral/Bilateral Fixator (K941048)
• Orthofix Modulsystem (XCaliber) (K955848)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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

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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 Ricadona<br>Quality & Regulatory Affairs Manager |
|----------------|-----------------------------------------------------------|
| Address | Via delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| email | [e-mail] |

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<br>Spatial Frame | K093047 | Smith and Nephew |
| True/Lok Monolateral/Bilateral<br>Fixator | K941048 | Orthofix (originally submitted by Applied<br>Osteo Systems, Inc.) |
| Orthofix Modulsystem (XCaliber) | K955848 | Orthofix |

| Description | The Subject device is a multilateral external fixation system. The System<br>can also be used with a web-based software component that is designed<br>to be used to assist the physician in creating a patient adjustment<br>schedule that assists in adjusting the six struts. The System can also be<br>used with other existing Orthofix external fixation components and screws<br>(such as TrueLok or X Caliber). |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Components of the system include:<br>• Full and 5/8 aluminum Rings<br>• Adjustable struts<br>• Aluminum strut clips (number and direction)<br>• Stainless steel instrumentation such as hex drivers, wrenches, and<br>pliers<br>• Implantable components such as half pins and wires<br>• Web-based software |

| Indications and<br>Intended Use | The TL-HEX System is intended for limb lengthening by metaphyseal or<br>epiphyseal distractions, fixation of open and closed fractures, treatment |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| of non-union or pseudoarthrosis of long bones and correction of bony or<br>soft tissue defects or deformities. Within this range, indications include: | |
| • Post-traumatic joint contracture which has resulted in loss of range of<br>motion | |
| • Fractures and disease which generally may result in joint contractures<br>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<br>Characteristics<br>and Substantial<br>Equivalence | Documentation was provided to demonstrate that the Orthofix TL-HEX<br>True Lok Hexapod System (TL-HEX) is substantially equivalent to the<br>Predicates Smith & Nephew Inc, Circular Spatial Frame (K093047),<br>True/Lok Monolateral/Bilateral Fixator (K941048), and Orthofix<br>Modulsystem (K955848). The TL-HEX System is substantially equivalent<br>to the predicate devices in intended use, indications for use, technological<br>characteristics, and labeling. |
| Performance Data | The potential hazards have been evaluated and controlled through a Risk<br>Management Plan.<br><br>All testing met or exceeded the requirements as established by the test<br>protocols and applicable standards. A review of the mechanical data<br>indicates that the hardware components of the Subject device are capable<br>of withstanding expected loads without failure. Additionally, software<br>verification and validation testing was completed in conformance with<br>FDA's guidance document entitled "General Principles of Software<br>Validation; Final Guidance for Industry and FDA Staff." The results of<br>software testing indicate that the software performed as intended. The<br>results demonstrated that the Subject device presents no new worst case<br>for performance testing. The Subject device was therefore found to be<br>substantially equivalent to the Predicates. Clinical data was not needed<br>to support the safety and effectiveness of the Subject Device.<br>The following mechanical and software testing were performed:<br>• ASTM F 1541-02 (2007) e1 "Standard Specification and Test<br>Methods for External Skeletal Fixation Devices"<br>• ASTM F1541-01 Annex 7 "Test Method for External Skeletal Fixator-<br>Bone Constructs"<br>• ASTM F543-07 Annex A2 "Test Method for Driving Torque of<br>Metallic Bone Screws"<br>• Software IQ, OQ, PQ |
| Conclusion | Based on the indications for use, technological characteristics, materials,<br>and comparison to predicate devices, the Subject Orthofix TL-HEX True<br>Lok Hexapod System (TL_HEX) has been shown to be substantially |

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for its intended use.