(53 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI/ML algorithms or data analysis.
No
The device is described as an implant system for fixation of fractures and repairs, which is a structural or supportive function, not a therapeutic (treating disease or illness) one.
No
Explanation: The device is described as an implantable system of plates and screws for fixation of fractures and repairs, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of plates, screws, and washers made of titanium alloy, which are physical hardware components. The performance studies also focus on mechanical testing of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults." This describes a surgical implant used for structural support and repair within the body.
- Device Description: The description details plates, screws, and washers made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Activ Ankle range is intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Activ Ankle range consists of plates with screws designed for fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults. Washers are also available for use with screws. The implants of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial A) contain implants and instruments, or instruments only. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and ISO 5832-3).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal and the diaphyseal fibula, the distal tibia
Indicated Patient Age Range
adults
Intended User / Care Setting
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)
The following tests were conducted:
- Comparative static bend test. (ASTM F382)
- Comparative fatigue bend test. (ASTM F382)
- Endotoxins testing is performed using LAL quantitative kinetic chromogenic method.
No clinical studies were performed.
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.
K143061, K131093, K113652, K152289, K172596
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 16, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Newclip Technics % J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K173641
Trade/Device Name: Activ Ankle Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 17, 2017 Received: November 24, 2017
Dear Mr. 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 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.
1
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Activ Ankle
Indications for Use (Describe)
The Activ Ankle range is intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| 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 |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters 'nc' stacked on top of each other inside of a circle. The 't' in 'nc' is stylized with an upward-pointing arrow. The words 'NEWCLIP-TECHNICS' are written in all caps below the circle.
510 (k) Summary for the ACTIV ANKLE range 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Activ Ankle range.
Summary preparation date: October 25, 2017
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICS | |
| P.A. de la Lande Saint Martin | |
| 45 rue des Garottières | |
| F-44115 Haute-Goulaine - France | |
| Telephone: (33) 2 28 21 37 12 | J.D. Webb |
| The OrthoMedix Group, Inc. | |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| Telephone: 512-388-0199 | |
| 2. Trade name: | Activ Ankle |
| Common Name: | Plate, Fixation, Bone / Screw, Fixation, bone |
| Product code: | HRS - Plate, Fixation, Bone |
| HWC - Screw, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone |
| fixation appliances and accessories. | |
| (21 CFR part. 888.3030) | |
| Smooth or threaded metallic bone | |
| fixation fastener (21 CFR part. 888.3040) |
4
Image /page/4/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters "nct" inside of a circle. The "t" in "nct" has an upward-pointing arrow as part of the letter. The words "NEWCLIP-TECHNICS" are written in all caps below the circle.
3. Primary predicate or legally marketed devices which are substantially equivalent:
- Activ Ankle Locking Plating System of Newclip Technics (K143061) .
Secondary predicate or legally marketed devices which are substantially equivalent:
- Ortholoc® 3Di Ankle Fracture System of Wright Medical Technology . (K131093)
- Small Fragment Set 3.5 of AAP Implantate AG (K113652) .
- . Alians Elbow Locking Plating System (K152289)
- Large Screws of Newclip Technics (K172596) .
| 4. Description of the device: | The Activ Ankle range consists of plates with screws designed for fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults. Washers are also available for use with screws. The implants of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial A) contain implants and instruments, or instruments only |
|---|---|
| ------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and ISO 5832-3).
provided sterile by gamma sterilization.
- Function: The implants of Activ Ankle range are intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
5
Image /page/5/Picture/1 description: The image shows the logo for New Clip-Technics. The logo consists of a circle containing the letters "nct" in lowercase. The "t" in "nct" is stylized with an upward-pointing arrow. Below the circle, the words "NEW CLIP-TECHNICS" are written in a sans-serif font, with a hyphen separating "CLIP" and "TECHNICS".
5. Substantial equivalence claimed to predicate devices:
The Activ Ankle range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
6. Intended use:
The Activ Ankle range is indicated for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative static bend test. (ASTM F382) ●
- . Comparative fatigue bend test. (ASTM F382)
- Endotoxins testing is performed using LAL quantitative kinetic . chromogenic method.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip Technics considers the Activ Ankle 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.