(286 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical screw implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an osteosynthesis compressive single-use screw system designed for stable fixation of bones and bone fragments, which is a structural or supportive function rather than a therapeutic one (e.g., healing or treating disease).
No
Explanation: The device is a compressive screw system for bone fixation, correction, or stabilization, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a range of osteosynthesis compressive single use screws made of titanium alloy, which are hardware components. The performance studies also focus on the mechanical properties and sterilization of these physical screws.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description identifies it as an "osteosynthesis compressive single use screws, made of titanium alloy," and an "implantable medical device intended to be used in orthopedics for foot and ankle surgery." This further confirms its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information. The device's function is purely mechanical support and stabilization within the body.
N/A
Intended Use / Indications for Use
Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:
Ø5.0mm compressive screw:
- Os Calcis and talar fractures
- Calcaneus osteotomies
- Arthrodesis of the tarsals
Ø7.0mm compressive screw:
- Ankle arthrodesis
- Calcaneus osteotomies
Product codes
HWC
Device Description
Nexis® is a range of osteosynthesis compressive single use screws, made of titanium alloy, designed to address foot and ankle indications. These devices are designed for stable fixation and have quick insertion features.
They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and bone fragments of the foot and ankle
Indicated Patient Age Range
adult 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)
Non-clinical performance testing was conducted according to the FDA Guidance "orthopedic non-Spinal metallic bone screw and washers – Performance Criteria for safety and Performance based pathway" issued December 11, 2021. Tests performed include:
- Torsion resistance of the screws according to ASTM F543-17 and evaluated against a predicate device.
- Strength needed to insert and remove screws according to ASTM F543-17.
- Axial pull out resistance of the screws assessed using the equation described by Chapman et al., 1996.
- Sterilization and reprocessing validations according to ISO 11137-1, ISO 11607-1 and ISO 11607-2, demonstrating cleanliness and sterility assurance level of 10th.
- Biocompatibility of the device assessed using ISO 10993-1: 2018.
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
August 30, 2023
Image /page/0/Picture/1 description: The image shows 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 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.
Novastep Gilles Audic QA/RA director 2. allée Jacques Frimot Rennes. 350000 France
Re: K223468
Trade/Device Name: Nexis® compressive screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 1, 2023 Received: August 1, 2023
Dear Gilles Audic:
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 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
1
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 mediation-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 -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223468
Device Name Nexis® compressive screws
Indications for Use (Describe)
Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:
Ø5.0mm compressive screw:
- Os Calcis and talar fractures
- Calcaneus osteotomies
- Arthrodesis of the tarsals
Ø7.0mm compressive screw:
- Ankle arthrodesis
- Calcaneus osteotomies
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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3
510(k) summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Nexis® compressive screws.
SUBMITTER/510(K) HOLDER
Novastep® S.A.S 2, Allée Jacques Frimot 35000 Rennes France Phone: +33-2-99-33-86-50
Gilles Audic, Quality Affairs / Regulatory Affairs Director Contact: Contact Phone: +33-6-30-93-96-08 gilles.audic@novastep-ortho.com Contact Email: Date Prepared: November 17, 2022
DEVICE NAME
| Device name: | Nexis® compressive screws |
|---|---|
| Device Classification Name: | Screw, fixation, bone |
| Regulation Number: | 888.3040 |
| Classification Product Code: | HWC |
| Device Class: | Class II |
PREDICATE DEVICE
Primary Predicate
| Manufacturer: | Stryker Trauma AG |
|---|---|
| Device name: | FIXOS SCREW SYSTEM |
| Device Classification Name: | Screw, fixation, bone |
| 510(k) Number: | K133451 |
| Regulation Number: | 888.3040 |
| Classification Product Code: | HWC |
| Device Class: | Class II |
Additional Predicate
| Manufacturer: | WRIGHT MEDICAL TECHNOLOGY, INC. |
|---|---|
| Device name: | DARCO HEADLESS COMPRESSION SCREW |
| Device Classification Name: | Screw, fixation, bone |
| 510(k) Number: | K080850 |
| Regulation Number: | 888.3040 |
| Classification Product Code: | HWC |
| Device Class: | Class II |
Additional Predicate
| Manufacturer: | Novastep® S.A.S |
|---|---|
| Device name: | Nexis osteosynthesis compressive screw |
| Device Classification Name: | Screw, fixation, bone |
| 510(k) Number: | K143229 |
| Regulation Number: | 888.3040 |
| Classification Product Code: | HWC |
| Device Class: | Class II |
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DEVICE DESCRIPTION
Nexis® is a range of osteosynthesis compressive single use screws, made of titanium alloy, designed to address foot and ankle indications. These devices are designed for stable fixation and have quick insertion features.
They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.
INTENDED USE/INDICATION FOR USE
The intended use is:
-
. Osteosynthesis compressive screw
The indication for use is: -
그 Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:
Ø5.0mm compressive screw: -
Os Calcis and talar fractures o
-
Calcaneus osteotomies O
-
Arthrodesis of the tarsals O
Ø7.0mm compressive screw:
- o Ankle arthrodesis
- Calcaneus osteotomies o
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
Novastep® S.A.S. demonstrated that Nexis® compressive screws are substantially equivalent to the predicate devices, FIXOS SCREW SYSTEM (primary predicate device, K133451, cleared 28-Feb-2014) in term of intended use (including indication for use) and performance, DARCO HEADLESS COMPRESSION SCREW (additional predicate device, K080850, cleared 04-Oct-2008) in term of design characteristics and Nexis osteosynthesis compressive screws (secondary predicate device, K143229, cleared 02-Jun-2015) in term of the safety of the device, with equivalence on raw material, manufacturing process and biocompatibility. The subject device indications for use, technological characteristics and overall design are substantially equivalent to those of the predicate devices. Any minor differences in design and performance do not raise any questions of safety or effectiveness.
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Nexis® compressive screws have undergone functional testing to provide evidence that its non-clinical properties are substantially equivalent to predicate devices already cleared.
Functional tests have been done according to the FDA Guidance "orthopedic non-Spinal metallic bone screw and washers – Performance Criteria for safety and Performance based pathway" issued December 11, 2021:
- Torsion resistance of the screws must be assessed to prevent screw breakage during insertion or removal. -Test performed according to ASTM F543-17 and evaluated against a predicate device.
- -Strength needed to insert and remove screws must be evaluated to avoid failure of the screw during insertion or the removal.
- Tests performed according to ASTM F543-17.
- -Axial pull out resistance of the screws must be assessed to valid a suitable anchorage when subjected to tensile forces, poor bone quality or osteoporotic bone.
- Assessed using the equation described by Chapman et al., 1996.
- -Sterilization and reprocessing validations to demonstrate the cleanliness and the sterility of, and the ability to clean and sterility assurance level of 10th, the device and device-specific instruments.
Tests performed according to ISO 11137-1, ISO 11607-1 and ISO 11607-2.
5
Biocompatibility of the device. -Assessed using ISO 10993-1: 2018.
SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Not applicable. Clinical studies were not required for this submission.
CONCLUSIONS
Nexis® compressive screws are substantially equivalent to the predicate devices, FIXOS SCREW SYSTEM (K133451, cleared 28-Feb-2014) in term of intended use and performance, DARCO HEADLESS COMPRESSION SCREW (K080850, cleared 04-Oct-2008) in terms design and Nexis osteosynthesis compressive screws (K143229, cleared 02-Jun-2015) in terms of material, manufacturing process and biocompatibility. Any minor differences between these devices do not raise new questions of safety and effectiveness.