(95 days)
Not Found
No
The document describes a mechanical external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the "treatment of appropriately sized long bone (wrist and hand) fractures", indicating a therapeutic purpose.
No
The device is an external fixation system used for stabilizing bone fractures, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of physical components like fixation half-pins, rigid clamps, and adjustable telescoping tubes, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The FastFrame External Fixation System - Distal Radius is a physical device used to stabilize bone fractures. It is applied externally to the body and does not involve testing samples taken from the body.
- Lack of IVD-related information: The document does not mention any aspects related to laboratory testing, analysis of biological samples, or diagnostic purposes in the context of in vitro procedures.
Therefore, the FastFrame External Fixation System - Distal Radius is a medical device used for surgical and orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for:
-Stabilization of open or closed fractures, 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;
-
Stabilization of non-unions; 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 - Distal Radius. The systems consists of fixation half- pins attached to rigid clamps connected by adjustable telescoping tubes (bars) and are intended for use in the treatment of long bone fractures that require external fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone (wrist and hand)
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
Performance Evaluation – The mechanical testing confirmed that the subject device performs substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device. In addition, the FastFrame External Fixation System – Distal Radius was 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, ASTM F2052-14, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-07 (2013).
Key Metrics
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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2015
Zimmer, Incorporated Sujith M. Kallur Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K152484
Trade/Device Name: FastFrame™ External Fixation System - Distal Radius Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: KTT, JDW Dated: November 11, 2015 Received: November 12, 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 Parts 801); medical device reporting (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 (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" (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 (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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
FastFrame External Fixation System - Distal Radius
Indications for Use (Describe)
The FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for:
-Stabilization of open or closed fractures, 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;
-
Stabilization of non-unions; 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo features a stylized blue letter "Z" enclosed within a blue circle. Below the circle, the word "zimmer" is written in lowercase, using a modern, sans-serif font, also in blue.
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: | 08/28/2015 |
| Trade Name: | FastFrame™ External Fixation System - Distal Radius |
| 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 Small External Fixation System by Zimmer Inc.
K131413, cleared 28-Jan-2014
-XtraFix Small External Fixation System by Zimmer Inc.
K141697, cleared 18-Sep-2014 |
| Purpose and
Device Description: | The purpose of this 510(k) is to obtain marketing
clearance for the new device, the FastFrame External
Fixation System - Distal Radius. The systems consists of
fixation half- pins attached to rigid clamps connected by
adjustable telescoping tubes (bars) and are intended for
use in the treatment of long bone fractures that require
external fixation. |
| Intended Use/Indications for Use: | The FastFrame External Fixation System - Distal Radius
is indicated for use in treatment of appropriately sized long |
4
| bone (wrist and hand) fractures. Specifically, the system is intended for: | |
|---|---|
| - Stabilization of open or closed fractures, 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; | |
| - Stabilization of non-unions; 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 long bone anatomy of the wrist and hand. 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 a sterile kit as compared to the predicate system that is provided non-sterile, and must be steam sterilized prior to use. | |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Performance Evaluation – The mechanical testing confirmed that the subject device performs substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device. In addition, the FastFrame External Fixation System – Distal Radius was 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, ASTM F2052-14, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-07 (2013). |
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Conclusions: The results demonstrate that the device is substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.