(29 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI or ML.
No
This device is an implant used for small bone reconstruction and fusion, which is a structural or mechanical intervention, not a therapeutic treatment.
No
Explanation: The device is described as an implant for bone fixation and reconstruction, specifically for inter-digital repair and fusion of lesser toes. Its function is to provide structural support and facilitate healing, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical implant system made of medical grade stainless steel, including instruments. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "small bone reconstruction limited to inter-digital repair and fusion of the lesser toes." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is a "two-part 3.4mm diameter bone fixation implant" made of "medical grade stainless steel." This is a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used for structural support and fusion.
N/A
Intended Use / Indications for Use
The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Nextremity Solutions 3.4mm FlexFusion™ Fixation implant system consists of a two-part 3.4mm diameter bone fixation implant. The proximal and distal components are provided as a set and as a procedure pack with the necessary surgical site preparation and insertion instruments. The Nextremity Solutions FlexFusion™ Fixation Implant is fabricated from medical grade stainless steel and the design allows the clinician to establish a natural angulation of the fused inter-digital joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bone, inter-digital, lesser toes
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)
Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, driving torque, torque to failure, static and dynamic flexion extension resistance. Results from cadaver test labs were also presented.
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.
K050259, K990804, K022599, K070598
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
MAR 1 7 2011
510(k) Summary (Per 21 CFR 807.92)
General Company Information:
Nextremity Solutions, LLC Arthur A. Alfaro President/CEO 167 Stone Hill Road Colts Neck, NJ 07722 Phone: (732) 683-9304 Fax: (732) 683-9476
Date Prepared
March 14, 2011
General Device Information
Product Name:
Classification:
Predicate Device
Arthrex, Inc.
Pioneer Surgical Technology
NewDeal SA
Memometal Technologies, Inc.
Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259]
Smooth or threaded bone fixation fasteners,
StayFuse™ Fixation implant [510(k) Number K990804]
FlexFusion™ Fixation implant
Product code: HWC - Class II
NEWDEAL K Wire [501(k) K022599]
Memometal Intramedullary Arthrodesis Device [510(k) K070598]
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Description
The Nextremity Solutions 3.4mm FlexFusion™ Fixation implant system consists of a two-part 3.4mm diameter bone fixation implant. The proximal and distal components are provided as a set and as a procedure pack with the necessary surgical site preparation and insertion instruments. The Nextremity Solutions FlexFusion™ Fixation Implant is fabricated from medical grade stainless steel and the design allows the clinician to establish a natural angulation of the fused inter-digital joint.
Intended Use (Indications)
The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Substantial Equivalence
The Nextremity Solutions FlexFusion™ Fixation implant possesses the same technologic characteristics of the predicate devices. These include the intended use, basic design, material, size and fundamental technology.
Performance Data
Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, driving torque, torque to failure, static and dynamic flexion extension resistance. Results from cadaver test labs were also presented.
p. 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Nextremity Solutions, LLC % Mr. Arthur A. Alfaro President/CEO 167 Stone Hill Road Colts Neck, New Jersey 07722
MAR 1 7 201
Re: K110445
Trade/Device Name: FlexFusion Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 14, 2011 Reccived: February 16, 2011
Dear Mr. Alfaro:
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
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Page 2 - Mr. Arthur A. Alfaro
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 (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.
ff 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/ucm1117800 html br 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" (21CF) 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
My B. D. h
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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