(87 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a surgical implant system, with no mention of AI or ML.
Yes.
This device is intended for "small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes," which is a direct medical intervention to restore function and correct a condition.
No
The device is a PEEK Hammertoe Correction System, which is an implantable surgical system used for small bone reconstruction and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical implants (screws made of PEEK) and surgical instruments (drivers, taps, etc.). It also details non-clinical testing related to the strength of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Nextremity Solutions Nextra PEEK Hammertoe Correction System is a surgical implant consisting of screws and instruments used for bone reconstruction and fusion.
- Intended Use: The intended use is for "small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The device is a surgical implant used in a surgical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
Product codes
HWC
Device Description
The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. 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
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 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. To evaluate the strength of the Nextra PEEK Hammertoe Correction System and components, static 3-point bend tests and dynamic 3-point bend tests were performed on the worst case implant construct according to ASTM F2193-18a. These tests confirmed that the strength of the Nextra PEEK Hammertoe Correction System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use. Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra PEEK Hammertoe Correction System to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 23, 2021
Nextremity Solutions. Inc. Elise Fox Quality and Regulatory Specialist 1195 Polk Drive Warsaw, Indiana 46582
Re: K211996
Trade/Device Name: Nexta® PEEK 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 24, 2021 Received: June 28, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Nextra® PEEK Hammertoe Correction System
Indications for Use (Describe)
The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated 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: | September 22, 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 | |
| FAX: 574-966-1396 | |
| Proprietary Name: | Nextra PEEK Hammertoe Correction 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:
- Nextremity Solutions, Nextra CH Cannulated Hammertoe System (Cleared as DuoHex™ . CH Cannulated Hammertoe System), K200840-Primary Predicate
- . Smith & Nephew, Hat-Trick Lesser Toe Repair System PIP Fusion (Cleared as MTP Solutions LLC, PEEK Fusion Implant), K133515-Additional Predicate
- Arthrex, TRIM-IT Spin Pin (Cleared as Arthrex Bio-Pin), K050259-Additional Predicate ●
Device Description:
The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. The implants and instruments of the system are provided sterile for single use.
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Intended Use / Indications:
The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
Summary of Technologies/Substantial Equivalence:
The Nextra PEEK Hammertoe Correction 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. To evaluate the strength of the Nextra PEEK Hammertoe Correction System and components, static 3-point bend tests and dynamic 3-point bend tests were performed on the worst case implant construct according to ASTM F2193-18a. These tests confirmed that the strength of the Nextra PEEK Hammertoe Correction System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra PEEK Hammertoe Correction System to the predicate device.
Conclusions/Substantial Equivalence:
The Nextra PEEK Hammertoe Correction System is substantially equivalent to the predicate devices regarding its intended use, 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.