(223 days)
Not Found
No
The summary describes a mechanical external fixation system and does not mention any AI/ML components or capabilities.
Yes
The device is used for the "treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures" and 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." This aligns with the definition of a therapeutic device which directly treats a condition.
No
The XtraFix External Fixation System is described for the "construction of an external fixation frame for treatment" of fractures and other orthopedic conditions, indicating it is a therapeutic device used for physical stabilization rather than for diagnosing conditions.
No
The device description explicitly states that the system includes "various elements designed to build a fixator construct," including "new clamps and half pins," which are physical hardware components.
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 physical stabilization of bones and pelvis in the treatment of fractures, arthrodesis, osteotomies, and non-unions. This is a surgical/orthopedic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "External Fixation System" including clamps and half pins, which are physical components used to build a frame for external fixation. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The XtraFix External Fixation System does not fit this description.
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 o where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue problems; o
- Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. 0
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDW
Device Description
The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone (femur, tibia, foot and humerus) and pelvic
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 system was characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007), Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. The XtraFix External Fixation System Line Additions were also characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the devices can be used in an MR environment under predetermined conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K091258 and K111155, K031428, K994143
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 26 2012
XtraFix External Fixation System Line Additions 510(k) Summary
| Device Manufacturer: | ExtraOrtho, Inc.
8275 Tournament Drive, Suite 160
Memphis, TN 38125 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | November 16, 2011 |
| Contact Person: | Brian Austin
Tel: 1-901-748-2581
Fax: 1-901-748-2583 |
| Proprietary Name: | XtraFix External Fixation System Line Additions |
| Common Name: | External Fixation Frame Components |
| Classification regulation: | 888.3030 Single/multiple component metallic bone
fixation appliances and accessories, 888.3040 Smooth or
threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Codes: | KTT and JDW/ Orthopedics/87 |
Device Description and Intended Use:
The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.
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 o where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue problems; o
- Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. 0
Predicate Devices:
The XtraFix External Fixation System Line Additions are similar to several predicates including the following:
1
KI) 3383
XtraFix External Fixation System Line Additions 510(k) Summary
- Synthes Large External Fixation Clamps- MR S (K031428); and
- Smith & Nephew Jet-X Unilateral Fixator (K994143).
Technological Characteristics
The principles of operation of the XtraFix External Fixation System Line Additions are the same as for the predicates. The system was characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007), Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. The XtraFix External Fixation System Line Additions were also characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the devices can be used in an MR environment under predetermined conditions. Therefore, the term "MR Conditional" can be used to describe the system in accordance with the guidance document.
Substantial Equivalence Information:
The XtraFix External Fixation System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the XtraFix External Fixation System is substantially equivalent to the predicate devices.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 26 2012
Extraortho, Inc. c/o Marcos Velez-Duran President of MSquared Associates, Inc. 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K113383
Trade/Device Name: XtraFix External Fixator 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: April 6, 2012 Received: April 9, 2012
Dear Mr. Velez-Duran:
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
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Eunice Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K11 33883
Indications for Use Statement
To be assigned 510(k) Number:
XtraFix External Fixation System Device Name:
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 i is intended for:
Stabilization of open or closed fractures, typically in the context of polytrauma or O where open or alternative closed treatment is undesirable or otherwise contraindicated;
- o Arthrodesis and osteotomies with associated soft tissue problems;
- o Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. O
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Autsit
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113383
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