Dolphix® External Fixation System MR Conditional

K163323 · Citieffe S.R.L. · KTT · Mar 20, 2017 · Orthopedic

Device Facts

• Record ID: K163323
• Device Name: Dolphix® External Fixation System MR Conditional
• Applicant: Citieffe S.R.L.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods. Dolphix® External Fixation System MR Conditional is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for: - Temporary stabilization of open or closed acute fractures with soft tissue injuries; - Temporary stabilization of fractures in the context of polytrauma; - Temporary stabilization of certain pelvic fractures or pelvic ring injuries; - Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure: - Temporary stabilization of non-unions; - Intra-operative temporary stabilization tool to assist with indirect reduction. Dolphix® External Fixation System MR Conditional is intended for use in a non-weight bearing patient.

Device Story

Dolphix® External Fixation System MR Conditional consists of metallic bone screws, clamps, and rods; assembled into external fixation frames. Used by surgeons in clinical settings for temporary stabilization of long bone and pelvic fractures; provides structural support for non-weight bearing patients. Device facilitates fracture reduction and stabilization; MR conditional status allows for imaging compatibility. System components are manually assembled by clinicians to create custom constructs tailored to patient anatomy and fracture type.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison.

Technological Characteristics

Metallic external fixation system comprising bone screws, clamps, and rods. Designed for MR conditional use. Components are manually assembled to form rigid frames. Sterilization is required for clinical use.

Indications for Use

Indicated for temporary stabilization of long bone and pelvic fractures, including open/closed acute fractures with soft tissue injury, polytrauma, pelvic ring injuries, post-arthroplasty limb stabilization, and non-unions; also used as an intra-operative tool for indirect reduction. Intended for non-weight bearing patients.

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.

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

March 20, 2017

CITIEFFE s.r.1. % Marisa Testa CEO & QA/RA Manager Thelma s.r.l Via Saragat, 5 Imola 40026 Italy

Re: K163323

Trade/Device Name: Dolphix® External Fixation System MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: February 3, 2017 Received: February 23, 2017

Dear Ms. Testa:

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,

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) K163323

Device Name

Dolphix® External Fixation System MR Conditional

## Indications for Use (Describe)

Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods. Dolphix® External Fixation System MR Conditional is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:

- Temporary stabilization of open or closed acute fractures with soft tissue injuries;
- Temporary stabilization of fractures in the context of polytrauma;
- Temporary stabilization of certain pelvic fractures or pelvic ring injuries;
- Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure:
- Temporary stabilization of non-unions;
- Intra-operative temporary stabilization tool to assist with indirect reduction.

Dolphix® External Fixation System MR Conditional is intended for use in a non-weight bearing patient.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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