(90 days)
Not Found
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or AI/ML terms.
No.
The device is an implantable system for bone fusion and repair, not a device used to provide therapy or treatment.
No
This device is a surgical implant (Hammertoe Correction System) used for small bone reconstruction and fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components fabricated from titanium alloy, which are hardware.
Based on the provided information, the Nextra™ Ti Hammertoe Correction System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 description clearly states that the Nextra™ Ti Hammertoe Correction System is a surgical implant used for "small bone reconstruction limited to inter-digital repair and fusion of the lesser toes." This is a device implanted in the body for structural support and repair, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, analysis, or diagnostic testing.
Therefore, the Nextra™ Ti Hammertoe Correction System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nextra™ Ti Hammertoe Correction System 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 Nextra™ Ti Hammertoe Correction (Nextra) System consists of proximal and distal components provided as a set with the necessary surgical site preparation and insertion instruments in a procedure pack. Nextra is fabricated from medical grade titanium alloy (6Al-4V) and the design allows the clinician to establish a natural angulation of the fused interdigital joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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.
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
K122031 *#1/2
510(k) Summary (Per 21 CFR 807.92)
General Company Information:
Nextremity Solutions, Inc. Arthur A. Alfaro President/CEO 167 Stone Hill Road Colts Neck, NJ 07722 Phone: (732) 683-9304 Fax: (732) 683-9476
Date Prepared
July 9, 2012
General Device Information
Product Name:
Classification:
Smooth or threaded bone fixation fasteners, Product code: HWC - Class II
Nextra™ Ti Hammertoe Correction System
Predicate Devices
Nextremity Solutions, LLC
FlexFusion™ Fixation implant [510(k) K110445]
Arthrex, Inc.
Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259]
Description
The Nextremity Solutions Nextra™ Ti Hammertoe Correction (Nextra) System consists of proximal and distal components provided as a set with the necessary surgical site preparation and insertion instruments in a procedure pack. Nextra is fabricated from medical grade titanium alloy (6Al-4V) and the design allows the clinician to establish a natural angulation of the fused interdigital joint.
Intended Use (Indications)
The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
1
K122031 #2/a
Substantial Equivalence
The Nextra™ Ti Hammertoe Correction System possesses the same technologic characteristics of the predicate devices. These characteristics 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
9 2012
Nextremity Solutions, LLC % Mr. Arthur A. Alfaro President, Chief Executive Officer 167 Stone Hill Road Colts Neck, New Jersey 07722
Re: K122031
Trade/Device Name: Nextra™ Ti Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 9, 2012 Received: June 11, 2012
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 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
3
Page 2 – Mr. Arthur A. Alfaro
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 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,
Einal Keith
/ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K | 2 d 0 3 |
Device Name: Nextremity Solutions, Nextra™ Ti Hammertoe Correction System
Indications For Use:
The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ash
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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