(88 days)
Not Found
No
The device description and performance studies focus on mechanical properties and structural integrity, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for the treatment of various injuries and conditions, such as fractures, arthrodesis, osteotomies, and non-unions, which falls under the scope of therapeutic applications.
No
Explanation: The FastFrame External Fixation System - Ankle Spanning is used for the treatment and stabilization of fractures and other conditions, which is a therapeutic function, not a diagnostic one. It does not provide any information about the patient's condition.
No
The device description explicitly states the system consists of physical components like fixation pins, clamps, and tubes, which are hardware.
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 the treatment of fractures and other conditions of the ankle and foot through external fixation. This is a therapeutic intervention performed directly on the patient.
- Device Description: The description details mechanical components (pins, clamps, tubes) used for external fixation, which is a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for 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.
Product codes
KTT, JDW
Device Description
The purpose of this 510(k) is to obtain marketing clearance for the new device, the FastFrame External Fixation System - Ankle Spanning. The system consists of fixation half- pins and transfixing full-pins attached to rigid clamps connected by adjustable telescoping tubes (bars). The system is intended for use in the treatment of fractures about the ankle that require external fixation. The system also contains a separately sterile packaged FastFrame External Fixation System - Ankle Spanning Optional Clamp Assembly. This Optional Clamp Assembly is included as an optional accessory that allows the surgeon to hold the foot in a fixed position post-operatively, if desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia and foot / ankle
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)
Non-Clinical Performance and Conclusions: Performance Evaluation – The mechanical testing confirmed that the subject devices perform substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device. In addition, the FastFrame External 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.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sujith M Kallur
Regulatory Affairs Specialist, Trauma Regulatory Affairs
Telephone: 574-453-6350
Fax: 574-871-8760 |
| Date: | 09/23/2015 |
| Trade Name: | FastFrame™ External Fixation System - Ankle Spanning |
| Common Name: | External Fixation Frame Components |
| Classification Names
and References: | Appliance, Fixation, Nail/Blade/Plate Combination,
Multiple Components (KTT) per 21 CFR 888.3030,
Single/multiple component metallic bone fixation
appliances and accessories and Pin, Fixation, Threaded
(JDW) per 21 CFR 888.3040, Smooth or threaded metallic
bone fixation fastener |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | XtraFix External Fixation System by Zimmer Inc.
K113383, cleared 6/26/2012 |
| Purpose and
Device Description: | The purpose of this 510(k) is to obtain marketing
clearance for the new device, the FastFrame External
Fixation System - Ankle Spanning. The system consists of
fixation half- pins and transfixing full-pins attached to
rigid clamps connected by adjustable telescoping tubes
(bars). The system is intended for use in the treatment of
fractures about the ankle that require external fixation. The
system also contains a separately sterile packaged
FastFrame External Fixation System - Ankle Spanning
Optional Clamp Assembly. This Optional Clamp
Assembly is included as an optional accessory that allows
the surgeon to hold the foot in a fixed position post-
operatively, if desired. |
| Intended Use/Indications for 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. |
| Comparison to Predicate Device: | Both the subject and predicate systems can be used to
reduce and fix tibial and foot anatomy. Both systems use
bars, clamps, and fixation pins to achieve the clinical end
result. Both systems allow for length distraction and
polyaxial motion between clamp bodies. |
| | The major difference between the subject and predicate
systems is that predicate system frame needs to be built
intra-operatively. The FastFrame External Fixation
System contains a frame which comes with clamps and
bars (telescoping tubes) pre-assembled, and are not
dissassemblable by the end user. The subject FastFrame
External Fixation System is provided in sterile kits as
compared to the predicate system that is provided non-
sterile, and must be steam sterilized prior to use. |
| | The FastFrame External Fixation System – Ankle
Spanning Optional Clamp Assembly was proven to be able
to hold a clinically relevant load over a specified period of
time. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
• Performance Evaluation – The mechanical testing |
| | confirmed that the subject devices perform
substantially equivalent in full construct rigidity and
interconnection performance as compared to the
predicate device. In addition, the FastFrame External |
4
5
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.