(103 days)
Not Found
No
The summary describes a mechanical implant system for bone fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis," which is a medical intervention to treat a condition.
No
Explanation: The device is an internal fixation system used for surgical fusion of foot bones, which is a treatment, not a diagnostic process.
No
The device description clearly states it consists of physical components (post, screws, post plug screw) made of Ti-6Al-4V alloy and includes accessory instruments for implantation. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation for Lesser Tarsometatarsal Joint Arthrodesis". This describes a surgical procedure to fuse bones, not a test performed on samples from the body to diagnose or monitor a condition.
- Device Description: The device is a "three-part construct intended for internal fixation". It consists of physical implants (post and screws) designed to be surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The Nextremity Solutions InCore® TMT System is a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/ 3rd Tarsometatarsal Fusion).
Product codes
HWC
Device Description
The InCore® TMT System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the cuneiform and compression screws are inserted into the metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lesser Tarsometatarsal Joint (also known as Lisfranc Joint or 2nd/ 3rd Tarsometatarsal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-Clinical Testing:
Endotoxin testing was performed on another Nextremity product which is considered worst case. Results met the endotoxin limit of
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 31, 2019
Nextremity Solutions. Inc. Elise Fox Quality Engineer 210 North Buffalo Street Warsaw, Indiana 46580
Re: K192578
Trade/Device Name: InCore TMT System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 31, 2019 Received: November 4, 2019
Dear Elise Fox:
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.
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
1
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 (QS) 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, M.P.H. 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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K192578 |
| Device Name | InCore® TMT System |
Indications for Use (Describe)
The Nextremity Solutions InCore® TMT System is a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/ 3rd Tarsometatarsal Fusion).
Type of Use (Select one or both, as applicable)
| | 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)
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| 510(k) Summary | |
|---|---|
| Prepared: | December 27th, 2019 |
| Submitter: | Nextremity Solutions, Inc. |
| 210 North Buffalo Street | |
| Warsaw, IN 46580 | |
| Contact: | Elise Fox |
| Quality Engineer | |
| elise.fox@nextremity.com | |
| Phone: 574-376-2062 | |
| FAX: 574-966-1396 | |
| Proprietary Name: | InCore® TMT System |
| Common Name: | Bone Screw System |
| Classification: | 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener; |
| Class II | |
| Product Code: | HWC |
Substantially Equivalent Devices:
- Extremity Medical Screw and Washer System (IO FiX), K121349-Primary Predicate
- Nextremity Solutions InCore® Lapidus System, K180257 ●
Device Description:
The InCore® TMT System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the cuneiform and compression screws are inserted into the metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136.
4
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
Intended Use / Indications:
The Nextremity Solutions InCore® TMT System is a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/ 3rd Tarsometatarsal Fusion).
Summary of Technologies/Substantial Equivalence:
The InCore® TMT System is substantially equivalent to the predicate devices in regard to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.
Non-Clinical Testing:
Endotoxin testing was performed on another Nextremity product which is considered worst case. Results met the endotoxin limit of