(34 days)
Not Found
No
The device description focuses on the mechanical components (screws, K-wires, instruments) and materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are limited to non-clinical testing (endotoxin).
Yes
The device is an implantable screw system intended for "small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes," which directly treats a medical condition.
No
The device is described as a system for inter-phalangeal repair and fusion of lesser toes, consisting of bone screw implants and surgical instruments, which are therapeutic in nature rather than diagnostic.
No
The device description clearly details physical components such as bone screw implants, Kirschner wires, and surgical instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "two-part cannulated bone screw implant construct" made of titanium and stainless steel, along with surgical instruments. These are physical implants and tools used in surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided clearly describes a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Nextremity Solutions Nextra CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
Product codes (comma separated list FDA assigned to the subject device)
HWC, NDL
Device Description
The Nextra® CH Cannulated Hammertoe System (originally cleared as DuoHex™ CH Cannulated Hammertoe System- K200840) consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inter-phalangeal repair and fusion of the 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)
Non-Clinical Testing: Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra CH Cannulated Hammertoe System to the predicate device.
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
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 9, 2021
Nextremity Solutions. Inc. Elise Fox Quality and Regulatory Specialist 1195 Polk Drive Warsaw, Indiana 46582
Re: K213530
Trade/Device Name: Nextra® CH Cannulated Hammertoe System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, NDL Dated: November 4, 2021 Received: November 5, 2021
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.
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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 (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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K213530
Device Name
Nextra® CH Cannulated Hammertoe System
Indications for Use (Describe)
The Nextremity Solutions Nextra CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
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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| 510(k) Summary | |
|---|---|
| Prepared: | November 4, 2021 |
| Submitter: | Nextremity Solutions, Inc. |
| 1195 Polk Drive | |
| Warsaw, IN 46582 | |
| Contact: | Elise Fox |
| Quality and Regulatory Specialist | |
| elise.fox@nextremity.com | |
| Phone: 574-376-2062 | |
| Proprietary Name: | Nextra® CH Cannulated Hammertoe System |
| Common Name: | Screw, Fixation, Bone- Primary |
| Pin, Fixation, Smooth, Metallic | |
| Classification: | II |
| Regulation Number: | 21 CFR § 888.3040 Smooth or threaded metallic bone fixation fastener |
| Panel: | 87/Orthopedic |
| Product Code: | HWC- Primary, NDL |
Substantially Equivalent Devices:
- . Nextremity Solutions, Nextra® CH Cannulated Hammertoe System (cleared as DuoHexTM CH Cannulated Hammertoe System)- K200840- Predicate Device
Device Description:
The Nextra® CH Cannulated Hammertoe System (originally cleared as DuoHex™ CH Cannulated Hammertoe System- K200840) consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion
4
instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.
Intended Use / Indications:
The Nextremity Solutions Nextra CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
Summary of Technologies/Substantial Equivalence:
The modified Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate devices regarding the 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 using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra CH Cannulated Hammertoe System to the predicate device.
Conclusions/Substantial Equivalence:
Differences between modified Nextra CH Cannulated Hammertoe system and the predicate device do not raise new types of safety and effectiveness questions. The modified Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device in regard to its intended use, material, design, sizes, and mechanical properties.