(91 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and fixation capabilities of the titanium plate and screws, with no mention of AI or ML.
Yes.
The device is described as a bone fixation system intended for permanent implantation to provide fixation for the 5th metatarsal for various conditions, including fractures, joint fusion, and reconstruction, which fall under therapeutic interventions.
No
Explanation: The device description states it is a "bone fixation device" and its intended use is for "fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones." These functions are therapeutic, not diagnostic.
No
The device description clearly states it is a "single-use bone fixation device intended to be permanently implanted" and consists of a "titanium alloy plate and screws," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Javelin Tailor's Bunion Fixation System is a permanently implanted bone fixation device consisting of a plate and screws. It is used to physically stabilize and fix bones during surgical procedures.
- Intended Use: The intended use is for the fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for structural support and fixation within the body, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Javelin Tailor's Bunion Fixation System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Javelin Tailor's Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal. The plate has 4 screw-receiving holes and is designed to allow for intramedullary insertion and fixation at the proximal end. The associated 2.0mm to 3.0mm diameter titanium screws, locking and non-locking, are designed in lengths of 6 to 16mm. The system is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the foot (such as 5th metatarsal)
Indicated Patient Age Range
adults and adolescent (13-21 years of age) patients
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)
No FDA performance standards have been established for the Javelin Tailor's Bunion Fixation System. The following testing was performed:
- Static and dynamic bending (per ASTM F382)
- Axial pull-out (per ASTM F543)
- . Engineering analysis to evaluate screw mechanical strength
The results of these tests indicate that the Javelin Tailor's Bunion Fixation System is substantially equivalent to the predicate devices.
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.
K152312, K190365, K172148, K182949, K161524
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
December 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nvision Biomedical Technologies, Inc % Analaura Villarreal-Berain Extremity Project Engineer Nvision Biomedical Technologies 4590 Lockhill Selma San Antonio, Texas 78249
Re: K202657
Trade/Device Name: Javelin Tailor's Bunion 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: HRS, HWC Dated: September 10, 2020 Received: September 14, 2020
Dear Analaura Villarreal-Berain:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Javelin Tailor's Bunion Fixation System
Indications for Use (Describe)
The Javelin Tailor's Bunion Fixation System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.
| 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) |
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Image /page/3/Picture/1 description: The image shows the logo for NVision biomedical technologies. The logo has a stylized "N" with vertical lines on the left side. The text "biomedical technologies" is written in a smaller font size below the main logo.
510(k) Summary
DATE PREPARED
September 10, 2020
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE
Analaura Villarreal Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: (210) 545-3713 ext. 109 Email: analauravillarreal @nvisionbiomed.com
PROPRIETARY NAME OF SUBJECT DEVICE
Javelin™ Tailor's Bunion Fixation System
COMMON NAME
Plate, Fixation, Bone (primary) Screw, Fixation, Bone
DEVICE CLASSIFICATION
Product Codes: HRS (Primary), HWC Classification Regulations: 21 CFR 888.3030 (Primary): Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener; Class II
PREMARKET REVIEW
Orthopedic Device Panel
INDICATIONS FOR USE
The Javelin Tailor's Bunion Fixation System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.
DEVICE DESCRIPTION
The Javelin Tailor's Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal. The plate has 4 screw-receiving holes and is designed to allow for intramedullary insertion and fixation at the proximal end. The associated 2.0mm to 3.0mm diameter titanium screws, locking and non-locking, are designed in lengths of 6 to 16mm. The system is provided non-sterile.
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Image /page/4/Picture/0 description: The image shows the logo for Nvision biomedical technologies. The logo is black and gold. The word "Nvision" is written in a stylized font, with the "N" having a gold design on the left side. Below the word "Nvision" is the phrase "biomedical technologies" in a smaller, gold font.
PREDICATE DEVICE IDENTIFICATION
The Javelin Tailor's Bunion Fixation System is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | |
|---|---|---|
| K152312 | Normed* RECON System – V-TEK-IVP Plates and | |
| Screws | Primary Predicate | |
| K190365 | Paragon 28 Inc. Baby Gorilla/Gorilla Plating System | Additional Predicate |
| K172148 | Stryker Anchorage Bone Plating System | Additional Predicate |
| K182949 | Nvision Biomedical's Healix Compression Screw | |
| System | Additional Predicate | |
| K161524 | Nvision Biomedical's Tangis Anterior Cervical Plate | Additional Predicate |
- Subsequently acquired by Zimmer Inc.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Javelin Tailor's Bunion Fixation System. The following testing was performed:
- Static and dynamic bending (per ASTM F382)
- Axial pull-out (per ASTM F543)
- . Engineering analysis to evaluate screw mechanical strength
The results of these tests indicate that the Javelin Tailor's Bunion Fixation System is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the Javelin Tailor's Bunion Fixation System is substantially equivalent to the predicate devices. The subject plates are similar to the predicates in that the geometry, thicknesses and lengths are similar, they are intended for use with ancillary screws, and they incorporate the same number of ancillary screws. Furthermore, the ancillary screws are similar in size. The implants from the Javelin Tailor's Bunion Fixation System are manufactured using Titanium Alloy and the instruments using medical grade Stainless Steel, similar to the predicate.
CONCLUSION
Based on the testing performed, including static and dynamic bending, pull-out, and engineering analysis, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Javelin Tailor's Bunion Fixation System are assessed to be substantially equivalent to the predicate devices.