ORTHOFIX GALAXY WRIST

K141760 · Orthofix Srl · KTT · Dec 8, 2014 · Orthopedic

Device Facts

• Record ID: K141760
• Device Name: ORTHOFIX GALAXY WRIST
• Applicant: Orthofix Srl
• Product Code: KTT · Orthopedic
• Decision Date: Dec 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required. The indications for use include: - intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage; - polytrauma; - carpal dislocations; - unreduced fractures following conservative treatment; - bone-loss or other reconstructive procedures; - infection.

Device Story

Orthofix Galaxy Wrist is an external fixation system for wrist bone stabilization. Device comprises frames, bars, clamps, accessories, and instruments; used with commercially available Orthofix pins. Surgeon secures pins/wires to bone via clamps to create rigid frame. System allows fracture reduction, alignment restoration, and joint distraction/compression or mobilization. Used in clinical/surgical settings for trauma and orthopedic procedures. Provides mechanical stability to facilitate healing in fractures, dislocations, and reconstructive cases. Benefits patient by maintaining bone alignment during recovery.

Clinical Evidence

Bench testing only. No clinical data required. Mechanical testing performed per ASTM F1541. MRI compatibility testing performed per ASTM F2182, ASTM F2213, and ASTM F2052.

Technological Characteristics

External skeletal fixation device. Metallic components. Mechanical fixation via clamps and pins/wires. Tested per ASTM F1541 (mechanical), ASTM F2182 (RF heating), ASTM F2213 (torque), and ASTM F2052 (displacement force).

Indications for Use

Indicated for adult and pediatric patients requiring bone stabilization for intra-articular or extra-articular wrist fractures/dislocations (with/without soft tissue damage), polytrauma, carpal dislocations, unreduced fractures post-conservative treatment, bone-loss/reconstructive procedures, or infection.

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

• Synthes Small External Fixation System (K963618)
• Stryker Hoffmann II MRI Compact External Fixation System (K053038)
• Orthofix Penning Dynamic Wrist Fixator (K955848)
• Orthofix Galaxy Fixation system (K113770)

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

December 8, 2014

Orthofix Srl % Ms. Cheryl Wagoner Principal Consultant Cheryl Wagoner Consulting Po Box 15729 Wilmington, North Carolina 28408

Re: K141760

Trade/Device Name: Orthofix Galaxy Wrist Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 3, 2014 Received: November 4, 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 (reporting of medical device

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related 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 [phone] or [phone] 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 [phone] or [phone] 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) K141760

Device Name Orthofix Galaxy Wrist

Indications for Use (Describe)

The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.

The indications for use include:

- intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage:
- polytrauma;
- carpal dislocations;
- unreduced fractures following conservative treatment;
- bone-loss or other reconstructive procedures:
- infection.

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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Image /page/3/Picture/0 description: The image contains the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in a bold, sans-serif font. The "R" in "ORTHOFIX" has a registered trademark symbol next to it.

| Submitter | Orthofix Srl<br>Via delle Nazioni, 9<br>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 | November 25, 2014 | |
| Trade Name | Orthofix Galaxy Wrist | |
| Common Name | External Fixation Device and Accessories | |
| Panel Code | Orthopaedics/87 | |
| Classification Name | Single/multiple component metallic bone fixation appliances and<br>accessories | |
| Class | Class II | |
| Regulation Number | 21 CFR 888.3030 | |
| Product Code | KTT | |
| Device Name | 510(k) Number | Manufacturer |
| Synthes Small External<br>Fixation System | K963618 | Synthes |

| Device Name | 510(k) Number | Manufacturer | Description | The Orthofix Galaxy Wrist is a complimentary system for the current<br>Galaxy Fixation system, engineered specifically for the wrist. The<br>primary objective of the Galaxy Wrist is to offer the possibility of<br>distraction/compression and the mobilization of the joint. The device<br>includes various frames, bars, clamps, accessories and instruments. |
|----------------------------------------------------------------|---------------|--------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Synthes Small External<br>Fixation System | K963618 | Synthes | | The system is designed to be used with commercially available Orthofix<br>pins. The clamps enable the frame to be coupled to bone by securing<br>the pins/wires for the intended use. |
| Stryker Hoffmann II MRI<br>Compact External Fixation<br>System | K053038 | Stryker | | |
| Orthofix Penning Dynamic<br>Wrist Fixator | K955848 | Orthofix | | |
| Orthofix Galaxy Fixation<br>system | K113770 | Orthofix | | |

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| | The system allows the surgeon to:<br>- Position screws where the condition of the bone and soft tissues<br>permits<br>- Reduce the fracture in order to restore alignment |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications and<br>Intended Use | The Orthofix Galaxy Wrist external fixator is an orthopedic device,<br>intended to be used for bone stabilization in trauma and orthopedic<br>procedures, both on adults and pediatric patients as required.<br>The indications for use include:<br>- intra-articular or extra-articular fractures and dislocations of the wrist<br>with or without soft tissue damage;<br>- polytrauma;<br>- carpal dislocations;<br>- unreduced fractures following conservative treatment;<br>- bone-loss or other reconstructive procedures;<br>- infection. |
| Technological<br>Characteristics<br>and Substantial<br>Equivalence | Documentation was provided to demonstrate that the Orthofix Galaxy<br>Wrist is substantially equivalent to the legally marketed Predicates. The<br>Galaxy Wrist is substantially equivalent to the predicate devices in<br>intended use, indications for use, technological characteristics, and<br>labeling. The Galaxy Wrist is comparable to its predicate in size, shape<br>and materials. |
| Performance Data | The potential hazards have been evaluated and controlled through a<br>Risk Management Plan.<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 components of the Subject device are capable of<br>withstanding expected loads without failure. The Subject device was<br>therefore found to be substantially equivalent to the Predicates. Clinical<br>data was not needed to support the safety and effectiveness of the<br>Subject Device.<br>The following mechanical testing was performed:<br>- ASTM F 1541 "Standard Specification and Test Methods for<br>External Skeletal Fixation Devices"<br>MRI compatibility testing was also conducted per:<br>- ASTM F2182 "Standard test method for measurement of radio<br>frequency induced heating near passive implants during magnetic<br>resonance imaging"<br>- ASTM F2213 "Standard Test Method for Measurement of<br>Magnetically Induced Torque on Medical Devices in the Magnetic<br>Resonance Environment"<br>- ASTM F2052 "Standard Test Method for Measurement of<br>Magnetically Induced Displacement Force on Medical Devices in<br>the Magnetic Resonance Environment" |
| Conclusion | Based on the indications for use, technological characteristics,<br>materials, and comparison to predicate devices, the Subject Orthofix<br>Galaxy Wrist has been shown to be substantially equivalent to legally<br>marketed predicate devices. |

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