FastFrame External Fixation System-Ankle Spanning

K152755 · Zimmer, Inc. · KTT · Dec 21, 2015 · Orthopedic

Device Facts

• Record ID: K152755
• Device Name: FastFrame External Fixation System-Ankle Spanning
• Applicant: Zimmer, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Dec 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FastFrame External Fixation System - Ankle Spanning is indicated for use in treatment of distal tibia and foot fractures. Specifically, the system is intended for: - Stabilization of open or closed fractures about the ankle, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; - Arthrodesis and osteotomies with associated soft tissue problems about the ankle; - Stabilization of limbs after removal of total ankle arthroplasty for infection or other failure; - Stabilization of non-unions about the ankle; and - Intraoperative temporary stabilization to assist with indirect reduction.

Device Story

External fixation system for ankle-spanning stabilization. Components include fixation half-pins, transfixing full-pins, rigid clamps, and adjustable telescoping tubes (bars). Used in clinical settings by surgeons for fracture reduction and stabilization. System provides rigid construct to hold bone segments in position; optional clamp assembly allows post-operative foot positioning. Provided as pre-assembled, sterile kits, eliminating intra-operative frame construction required by predicate. Benefits include reduced surgical time and stable fixation for complex ankle trauma or revision cases.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical mechanical performance testing confirming construct rigidity and interconnection performance, and MRI conditional safety evaluation.

Technological Characteristics

Metallic bone fixation system. Components: fixation pins, rigid clamps, telescoping tubes. Pre-assembled, non-disassemblable frame. Sterile delivery. MRI Conditional per FDA 2014 guidance.

Indications for Use

Indicated for patients with distal tibia and foot fractures requiring stabilization, including open/closed fractures (polytrauma), arthrodesis, osteotomies with soft tissue issues, post-total ankle arthroplasty failure, and non-unions.

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

• XtraFix External Fixation System (K113383)

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 21, 2015

Zimmer, Incorporated Sujith Kallur Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46851-0708

Re: K152755

Trade/Device Name: FastFrame™ External Fixation System-Ankle Spanning 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: September 23, 2015 Received: September 24, 2015

Dear Sujith Kallur:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

### 510(k) Number (if known)

K152755

#### Device Name

FastFrame External Fixation System - Ankle Spanning

Indications for Use (Describe)

The FastFrame External Fixation System - Ankle Spanning is indicated for use in treatment of distal tibia and foot fractures. Specifically, the system is intended for:

- Stabilization of open or closed fractures about the ankle, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;

- Arthrodesis and osteotomies with associated soft tissue problems about the ankle;

- Stabilization of limbs after removal of total ankle arthroplasty for infection or other failure;
- Stabilization of non-unions about the ankle; and
- Intraoperative temporary stabilization to assist with indirect reduction.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sujith M Kallur<br>Regulatory Affairs Specialist, Trauma Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | 09/23/2015 |
| Trade Name: | FastFrame™ External Fixation System - Ankle Spanning |
| Common Name: | External Fixation Frame Components |
| Classification Names<br>and References: | Appliance, Fixation, Nail/Blade/Plate Combination,<br>Multiple Components (KTT) per 21 CFR 888.3030,<br>Single/multiple component metallic bone fixation<br>appliances and accessories and Pin, Fixation, Threaded<br>(JDW) per 21 CFR 888.3040, Smooth or threaded metallic<br>bone fixation fastener |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | XtraFix External Fixation System by Zimmer Inc.<br>K113383, cleared 6/26/2012 |
| Purpose and<br>Device Description: | The purpose of this 510(k) is to obtain marketing<br>clearance for the new device, the FastFrame External<br>Fixation System - Ankle Spanning. The system consists of<br>fixation half- pins and transfixing full-pins attached to<br>rigid clamps connected by adjustable telescoping tubes<br>(bars). The system is intended for use in the treatment of<br>fractures about the ankle that require external fixation. The<br>system also contains a separately sterile packaged<br>FastFrame External Fixation System - Ankle Spanning<br>Optional Clamp Assembly. This Optional Clamp<br>Assembly is included as an optional accessory that allows<br>the surgeon to hold the foot in a fixed position post-<br>operatively, if desired. |
| Intended Use/Indications for Use: | The FastFrame External Fixation System - Ankle<br>Spanning is indicated for use in treatment of distal tibia<br>and foot fractures. Specifically, the system is intended for: |
| | - Stabilization of open or closed fractures about the<br>Ankle, typically in the context of polytrauma or<br>where open or alternative closed treatment is<br>undesirable or otherwise contraindicated; |
| | - Arthrodesis and osteotomies with associated soft<br>tissue problems about the ankle; |
| | - Stabilization of limbs after removal of total ankle<br>arthroplasty for infection or other failure; |
| | - Stabilization of non-unions about the ankle; and |
| | - Intraoperative temporary stabilization to assist<br>with indirect reduction. |
| Comparison to Predicate Device: | Both the subject and predicate systems can be used to<br>reduce and fix tibial and foot anatomy. Both systems use<br>bars, clamps, and fixation pins to achieve the clinical end<br>result. Both systems allow for length distraction and<br>polyaxial motion between clamp bodies. |
| | The major difference between the subject and predicate<br>systems is that predicate system frame needs to be built<br>intra-operatively. The FastFrame External Fixation<br>System contains a frame which comes with clamps and<br>bars (telescoping tubes) pre-assembled, and are not<br>dissassemblable by the end user. The subject FastFrame<br>External Fixation System is provided in sterile kits as<br>compared to the predicate system that is provided non-<br>sterile, and must be steam sterilized prior to use. |
| | The FastFrame External Fixation System – Ankle<br>Spanning Optional Clamp Assembly was proven to be able<br>to hold a clinically relevant load over a specified period of<br>time. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>• Performance Evaluation – The mechanical testing |
| | confirmed that the subject devices perform<br>substantially equivalent in full construct rigidity and<br>interconnection performance as compared to the<br>predicate device. In addition, the FastFrame External |

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Fixation System – Ankle Spanning and FastFrame External Fixation System – Ankle Spanning when used with the FastFrame External Fixation System -Ankle Spanning Optional Clamp Assembly were found to be MRI Conditional per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on December 11, 2014.

Conclusions: The results demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices to show substantial equivalence.