(92 days)
No
The device description and performance studies focus on the mechanical properties and intended use of bone screws, with no mention of AI or ML technologies.
Yes
The device is described as "intended for the fixation of bone fractures, fusions and osteotomies," which are medical treatments for conditions.
No
This device is a surgical implant (screws) intended for the fixation of bone fractures and other orthopedic conditions. It does not perform any diagnostic function.
No
The device description clearly states it consists of "screws designed for the fixation of bone fractures," which are physical implants made of titanium alloy. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a device used for the fixation of bone fractures, fusions, and osteotomies. This is a surgical implant used directly within the body to provide structural support and stability to bones.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Large Screws range falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Large Screws range is intended for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
Product codes
HWC
Device Description
The Large Screws range consists of screws designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
The Large Screws range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-12a and/or ISO 5832-3).
Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription Use, health care professionals
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 Test Summary:
The following tests were conducted:
- Comparative torsional tests.
- Comparative pullout engineering analysis.
- Driving torque tests.
Clinical Test Summary:
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000080 and K024060, K071639, K050346
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 & Human Services. The logo consists of a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Newclip Technics % J.D. Webb Official Correspondent The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K160617
Trade/Device Name: Large Screws Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 1, 2016 Received: April 4, 2016
Dear J.D. Webb:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - J.D. Webb
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/ResourcesforYou/Industry/default.htm. 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
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160617
Device Name
LARGE SCREWS range
Indications for Use (Describe)
The Large Screws range is intended for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
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)
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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Image /page/3/Picture/0 description: The image shows the logo for Newclip-Technics. The logo consists of the letters "nct" in a circle, with an arrow pointing upwards above the "t". Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font. The logo is simple and modern, and the arrow suggests growth or progress.
510 (k) Summary for the Large Screws range 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Large Screws range.
Summary preparation date: April 13, 2015
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICS | J.D. Webb |
| P.A. de la Lande Saint Martin | The OrthoMedix Group, Inc. |
| 45 rue des Garottières | 1001 Oakwood Blvd |
| F-44115 Haute-Goulaine - France | Round Rock, TX 78681 |
| Telephone: (33) 2 28 21 37 12 | Telephone: 512-388-0199 |
| 2. Trade name: | Large Screws range |
| Common Name: | Large Screws |
| Product code: | HWC |
| Classification Name: | Screw, Fixation, Bone |
| (21 CFR part. 888.3040) |
3. Primary predicate or legally marketed devices which are substantially equivalent:
Secondary predicate or legally marketed devices which are substantially equivalent:
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Image /page/4/Picture/0 description: The image shows the logo for Newclip Technics. The logo consists of a circle with the letters 'nct' inside. The 't' has a red arrow pointing upwards. Below the circle, the words 'NEWCLIP-TECHNICS' are written in a sans-serif font.
| 4. Description of the device: | The Large Screws range consists of
screws designed for the fixation of bone
fractures, pseudarthroses, fusions and
osteotomies of foot and ankle as well as
medium and large bone fragments
including radius, humerus, femur, tibia in
adults. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Large Screws range will be provided
non sterile for sterilization by health care
professionals prior to use or provided
sterile by gamma sterilization. |
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform
to ASTM F 136-12a and/or ISO 5832-3). |
| Function: | The implants of the Large Screws range
are indicated for the fixation of bone
fractures, pseudarthroses, fusions and
osteotomies of foot and ankle as well as
medium and large bone fragments
including radius, humerus, femur, tibia in
adults. |
5. Substantial equivalence claimed to predicate devices:
The Large Screws range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
The technological characteristics of the Large Screws are the same as the characteristics of predicate devices in terms of intended use and design. All of these screws have the following characteristics:
- Self-tapping -
- Cannulated -
- Available in titanium alloy -
- Partially or totally threaded -
- Available sterile or non-sterile -
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Image /page/5/Picture/0 description: The image shows the logo for Newclip-Technics. The logo consists of a circle with the letters "nct" inside. The "t" is red and has an arrow pointing upwards. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
- Equivalent size ranges -
- Equivalent diameters ranges -
6. Indications for use:
The Large Screws range is indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative torsional tests. .
- Comparative pullout engineering analysis. .
- Driving torque tests. .
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip Technics considers the Large Screws range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.