(86 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and MRI compatibility of the external fixation system components, with no mention of AI or ML.
Yes
The device is clearly indicated for the "treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation" and "treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation," explicitly stating its role in treating medical conditions.
No
The device is described as an external fixation system used for stabilizing fractures, arthrodesis, osteotomies, and non-unions. Its intended use focuses on treatment and stabilization, not on diagnosing medical conditions.
No
The device description explicitly states that the system includes physical components such as clamps, bars, and half pins, which are assembled to construct an external fixation frame. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an external fixation system for treating bone fractures and related conditions. This involves direct application to the patient's body for structural support and stabilization.
- Device Description: The description details components like clamps, bars, and pins that are used to construct a frame for external fixation. This is consistent with a surgical/orthopedic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body. The purpose is mechanical stabilization.
IVD devices are used in vitro (outside the body) to examine specimens for diagnostic purposes. This device is used in vivo (within the body or applied externally to the body) for therapeutic and structural support.
N/A
Intended Use / Indications for Use
The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure;
-Stabilization of non-unions; and
-Intraoperative temporary stabilization tool to assist with indirect reduction.
The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure;
- Stabilization of non-unions; and
- Intraoperative temporary stabilization tool to assist with indirect reduction.
Product codes
KTT, JDW
Device Description
The purpose of this traditional 510(k) is to seek clearance to market the line additions to the XtraFix Large and Small Systems. This traditional 510(k) also covers the proposed change to add a MRI conditional symbol on the existing carbon fiber bars in the XtraFix Large System so that the XtraFix Large System constructs with carbon fiber bars can be used in the MR environment (entirely outside the bore of the MRI scanner).
A Bar to Pin, 2D, independent locking clamp and a half pin are being added to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D, independent locking clamp and carbon fiber bars are being added to the XtraFix Small System. The XtraFix Large and Small Systems include the following elements: clamps, bars and half pins. The XtraFix Large and Small Systems are designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone (femur, tibia, foot, humerus, arm, wrist, hand) and pelvic fractures.
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)
The line additions to the XtraFix Large and Small Systems have been characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2011) e1 Standard Specification and Test Methods for External Fixation Devices and FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. Static axial & torsional grip strength testing and the rigidity analyses confirmed that the line additions to the XtraFix Large and Small Systems are substantially equivalent to the predicate devices.
In addition, the XtraFix Large System with carbon fiber bars was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21, 2008. The MRI conditional claim is supported by the following:
- Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity;
- The device components do not experience a measurable torque in a 3T static field:
- With the worst-case construct placed 50cm away from the center of the magnet of a MR scanner (64 MHz) the heating was at most 4.5 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg
- With the worst-case construct placed 50cm away from the center of the magnet of a MR scanner (128 MHz) the heating was at most 2.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
- Largest image artifact did not extend more than 60mm from the device.
Also, the XtraFix Small System with carbon fiber bars was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21, 2008. The MRI conditional claim is supported by the following:
- Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity;
- The device components do not experience a measurable torque in a 3T static field:
- With the worst-case construct placed 50cm away from the center of the MR scanner (64 MHz) bore the heating was at most 1.3 ℃ following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
- With the worst-case construct placed 50cm away from the center of the MR scanner (128 MHz) bore the heating was at most 3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
- Largest image artifact did not extend more than 63mm from the device.
Clinical data and conclusions were not needed 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.
0
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 a human figure, represented by three overlapping profiles, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2014
Zimmer, Incorporated Romil Sheth Specialist, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K141697
Trade/Device Name: Xtrafix® External Fixation System, Xtrafix® Small External Fixation System 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: June 23, 2014 Received: June 24, 2014
Dear Romil Sheth:
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K141697 (pg 1/2)
Device Name
XtraFix® External Fixation System
Indications for Use (Describe)
The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure;
-Stabilization of non-unions; and
-Intraoperative temporary stabilization tool to assist with indirect reduction.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
K141697 (pg 2/2)
Device Name
XtraFix® Small External Fixation System
The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure;
-
Stabilization of non-unions; and
-
Intraoperative temporary stabilization tool to assist with indirect reduction.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the symbol, 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: | Romil Sheth
Specialist, Trauma Regulatory Affairs, Zimmer, Inc.
Telephone: 574-371-1621
Fax: 574-371-8760 |
| Date Summary
Prepared: | 06/18/2014 |
| Trade Name: | 1) XtraFix® External Fixation System (also referred to as XtraFix
Large System)
2) XtraFix® Small External Fixation System (also referred to as
XtraFix Small System) |
| Common Name: | External Fixation Frame Components |
| Classification Name
and Reference: | XtraFix Large System
21 CFR 888.3030 - Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3040 - Smooth or threaded metallic bone fixation
fastener |
| | XtraFix Small System
21 CFR 888.3030 - Single/multiple component metallic bone
fixation appliances and accessories |
| Product Code: | XtraFix Large System
KTT and JDW |
| | XtraFix Small System
KTT |
| Classification Panel: | Orthopedic/87 |
5
| Predicate Device(s): | XtraFix Large System
-XtraFix External Fixation System, Zimmer, K113383 cleared on
06/26/2012
XtraFix Small System
-XtraFix Small External Fixation System, Zimmer, K131413 cleared
on 01/28/2014
-TransFx External Fixation System, Zimmer, K990848 cleared on
5/17/1999 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose and
Device Description: | The purpose of this traditional 510(k) is to seek clearance to market
the line additions to the XtraFix Large and Small Systems. This
traditional 510(k) also covers the proposed change to add a MRI
conditional symbol on the existing carbon fiber bars in the XtraFix
Large System so that the XtraFix Large System constructs with
carbon fiber bars can be used in the MR environment (entirely
outside the bore of the MRI scanner).
A Bar to Pin, 2D, independent locking clamp and a half pin are being
added to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D,
independent locking clamp and carbon fiber bars are being added to
the XtraFix Small System. The XtraFix Large and Small Systems
include the following elements: clamps, bars and half pins. The
XtraFix Large and Small Systems are designed in such a way that
several different types of frames can be assembled. Pins are inserted
into bone, and then clamps are assembled to the pins. Bars are
assembled to the clamps and a frame is constructed. After reducing
the fracture, all clamps are tightened to hold the frame in place. |
| Intended Use: | XtraFix Large System
The XtraFix External Fixation System is indicated for use in
construction of an external fixation frame for treatment of long
bone (femur, tibia, foot and humerus) and pelvic fractures that
require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure;
-Stabilization of non-unions; and
6
-Intraoperative temporary stabilization tool to assist with indirect reduction.
XtraFix Small System
The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure; -Stabilization of non-unions; and -Intraoperative temporary stabilization tool to assist with indirect reduction.
Summary of Technological Characteristics: The independent locking clamps being added to the XtraFix Large and Small Systems are intended to hold half pins and bars. These clamps allow for both their jaws to independently tighten upon the element (half pin/bar) they have grasped by tightening the respective nut. The half pin being added to the XtraFix Large System has a 6mm shank/major thread diameter; its overall length is 250mm and it has an 85mm long threaded portion. This half pin is made from 316L stainless steel (per ASTM F138). The bars being added to the XtraFix Small System are 6mm in diameter and have lengths ranging from 65mm to 300mm. These bars are made from carbon fiber/epoxy composite material. Performance Data (Nonclinical and/or The line additions to the XtraFix Large and Small Systems have been Clinical): characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2011) e1 Standard Specification and Test Methods for External Fixation Devices and FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. Static axial & torsional grip strength testing and the rigidity analyses confirmed that the line additions to the XtraFix Large and Small Systems are substantially equivalent to the predicate devices.
7
In addition. the XtraFix Large System with carbon fiber bars was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21, 2008. The MRI conditional claim is supported by the following,
-
Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity;
-
The device components do not experience a measurable torque in a 3T static field:
-
With the worst-case construct placed 50cm away from the center of the magnet of a MR scanner (64 MHz) the heating was at most 4.5 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg
-
With the worst-case construct placed 50cm away from the center of the magnet of a MR scanner (128 MHz) the heating was at most 2.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
-
Largest image artifact did not extend more than 60mm from the device.
Also, the XtraFix Small System with carbon fiber bars was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21, 2008. The MRI conditional claim is supported by the following,
-
Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity;
-
The device components do not experience a measurable torque in a 3T static field:
-
With the worst-case construct placed 50cm away from the center of the MR scanner (64 MHz) bore the heating was at most 1.3 ℃ following 15 minutes of exposure when scaled to a whole body SAR
level of 2.0 W/kg.
- With the worst-case construct placed 50cm away from the center of the MR scanner (128 MHz) bore the heating was at most 3 °C following 15 minutes of exposure when scaled to a whole body SAR
level of 2.0 W/kg. 5) Largest image artifact did not extend more than 63mm from the device.
Clinical data and conclusions were not needed to show substantial equivalence.
8
Substantial Equivalence Information:
The line additions to the XtraFix Large and Small Systems have same/similar indications for use, have same/similar design features, come in same/similar sizes, are made from same/similar material, and are provided non-sterile like their predicate devices. Further, performance testing and engineering rationales included in this submission demonstrate that any differences in technological characteristics do not adversely affect the safety and effectiveness of the line additions to the XtraFix Large and Small System.
Also, the indications for use, size, shape, materials and sterility of the existing carbon fiber bars in the XtraFix Large System to which we are proposing to add a MRI conditional symbol remain unchanged. Further, the MRI related testing and engineering rationales included in this submission demonstrate that using the carbon fiber bars in the MR environment (entirely outside the bore of MRI scanner) do not adversely affect the safety of the XtraFix Large System.