(95 days)
W-Fix (K070039)
No
The summary describes a mechanical bone screw and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a bone fixation device intended for permanent implantation to support osseous restoration, which is a structural or supportive function, not a therapeutic one as therapy implies treatment or healing of a disease or injury.
No
The device is described as "osteosynthesis compressive screws" and "bone fixation devices" used for "fixing and stabilizing the elective osteotomies," which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a physical, permanently implanted bone fixation device made of Titanium, not software.
Based on the provided information, the Nexis® osteosynthesis compressive screws are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only." This describes a surgical procedure involving the direct manipulation of bone tissue within the body.
- Device Description: The device is described as "single-use bone fixation devices intended to be permanently implanted." This further reinforces its use in a surgical context for structural support within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Nexis® screws does not involve any such testing of biological samples.
Therefore, the Nexis® osteosynthesis compressive screws are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
Product codes
HWC
Device Description
Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid foot bones and the metatarsal and phalanges of the foot
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
The biocompatibility evaluation for new devices Nexis® osteosynthesis snap-off screws was conducted in accordance with Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing)" and International Standard ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process) as recognized by FDA.
The new devices Nexis® osteosynthesis snap-off screws have similar technological characteristics in terms of design and mechanical characteristics (Driving and removal torque, pull-out strength, torsional resistance) and thus are believed to be substantially equivalent to the predicate Memometal Fixos screws (device reference: W-Fix) (K070039).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
NOVASTEP Mr. Gilles Audic OA/RA Director Espace Performance Alphasis - Batiment C1-C2 35769 Saint Gregoire France
Re: K143146
Trade/Device Name: Nexis® osteosynthesis snap-off screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 9, 2014 Received: December 12, 2014
Dear Mr. 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. 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
1
Page 2 - Mr. Gilles Audic
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section
(page 1/1)
4: Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Expiration Date: January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | |
| K143146 | |
| Device Name | |
| Nexis® osteosynthesis snap-off screws | |
| Indications for Use (Describe) | |
| The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective | |
| osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. | |
| 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. | |
| Type of Use (Select one or both, as applicable) | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the | |
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | |
| of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov |
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
Section
5: 510(k) Summary
| Submitter | NOVASTEP |
|---|---|
| Espace performance Alphasis | |
| Bâtiment C1-C2 | |
| 35769 SAINT GREGOIRE | |
| France | |
| Phone : + 33 (0)2 99 33 86 50 | |
| Fax :+ 33 (0)9 70 29 18 95 | |
| Contact person | Mister Gilles AUDIC |
| QA / RA Director | |
| Cell phone:+33 (0)6 30 93 96 08 | |
| e-mail: gilles.audic@novastep-ortho.com | |
| Preparation date | November 27th, 2014 |
"510(k) Summary" as required by section 807.92(c)
| Trade name | Nexis® osteosynthesis snap-off screws |
|---|---|
| Common Name | Screw, Fixation, Bone |
| Classification Name | Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, |
| product code HWC) | |
| Regulatory class | II |
| Legally marketed
predicate devices | 510(k) number: K070039
Device name: Memometal Fixos screws
Original applicant: MEMOMETAL TECHNOLOGIES
This predicate has not been subject to a design-related recall. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Nexis® osteosynthesis snap-off screws are single-use bone fixation
devices intended to be permanently implanted. Nexis® osteosynthesis
snap-off screws are non canulated snap-off screws made of Titanium
(Alloy Ti-6Al-4V ELI). |
novastep - Siège Social / Service Client
Espace Performance - Alphasis - Bâtiment C1-C2 - 35769 SAINT-GREGOIRE Cedex - FRANCE
Tél. +33 (0)2 99 23 60 77 - Fax : +33 (0)9 70 29 18 95 Code A.P.E. : 3250A - NºSIRET : 752 292 797 00012 - Nº TVA Intracommunautaire FR 64 752 292 797
4
0°
| | Nexis® osteosynthesis snap-off screws are non canulated snap-off bone
screws which allow a permanent compression, thus supporting a secure
osseous restoration. |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Nexis® osteosynthesis compressive screws are single use devices
intended for the fixing and stabilizing the elective osteotomies of the mid
foot bones and the metatarsal and phalanges of the foot only. |
| Comparison of the
technological
characteristics with the
predicate device | The new devices Nexis® osteosynthesis snap-off screws have similar
technological characteristics in terms of material (ISO 5832-3 Implants For
Surgery -- Metallic Materials -- Part 3: Wrought Titanium 6-Aluminium 4-
Vanadium Alloy) and mechanical characteristics (ASTM F543-13 Standard
Specification and Test Methods for Metallic Medical Bone Screws) and
thus are believed to be substantially equivalent to the predicate
Memometal Fixos screws (device reference: W-Fix) (K070039). |
| Performance data | The biocompatibility evaluation for new devices Nexis® osteosynthesis
snap-off screws was conducted in accordance with Blue Book
Memorandum #G95-1 (Use of International Standard ISO-10993,
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing)"
and International Standard ISO 10993-1 (Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing Within a Risk Management
Process) as recognized by FDA.
The new devices Nexis® osteosynthesis snap-off screws have similar
technological characteristics in terms of design and mechanical
characteristics (Driving and removal torque, pull-out strength, torsional
resistance) and thus are believed to be substantially equivalent to the
predicate Memometal Fixos screws (device reference: W-Fix) (K070039). |
| Indication for use | The Nexis® osteosynthesis compressive screws are single use devices
indicated for the fixing and stabilizing the elective osteotomies of the mid
foot bones and the metatarsal and phalanges of the foot only. |
| Clinical studies | Clinical studies were not required for this submission |
| Animal Studies | Animal Studies were not required for this submission |
| Conclusion | Nexis® osteosynthesis snap-off screws are substantially equivalent to
their predicate devices Memometal Fixos screws (device reference: W-
Fix) (K070039), in terms of intended use and indications for use, material,
design and function. Any minor differences between these two devices
do not raise new questions of safety and effectiveness. |
1 nov astep - Siège Social / Service Client
Espace Performance - Alphasis - Batiment