(449 days)
No
The description focuses on the mechanical properties and materials of bone plates and screws, with no mention of AI or ML capabilities.
Yes
The device is intended for bone reconstruction of the ankle joint, which is a treatment for injuries or conditions affecting that area.
No
Explanation: The device is an implant for bone reconstruction and fixation, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "plates and screws" made of titanium, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bone reconstruction of the ankle joint, including fixation of fractures and osteotomies. This is a surgical procedure involving the physical repair of bone.
- Device Description: The device consists of plates and screws made of titanium, designed to be implanted in the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids.
The device described is a surgical implant used for orthopedic procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Activmotion S DTO range consists of plates and screws designed for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
The Activmotion S DTO range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use.
Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).
Function: The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint, ankle, distal tibia and fibula
Indicated Patient Age Range
adults
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)
The following tests were conducted:
- Engineering analysis and comparative 4-point-bending tests in static and dynamic condition were conducted to compare the bending strength of the subject device plates to the predicates. Static and dynamic tests were conducted according to ASTM F382.
- Engineering analysis: torsional, driving torque, and pullout tests according to ASTM F543 were performed on the subject screws.
- Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Activmotion S DTO range is as safe and as effective as the predicates.
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.
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.
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
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.
December 16, 2021
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K202803
Trade/Device Name: Activmotion S DTO 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 9, 2021 Received: November 15, 2021
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. 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.
1
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, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K202803
Device Name Activmotion S DTO
Indications for Use (Describe)
The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
| 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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Image /page/3/Picture/1 description: The image features a logo for "NEWCLIP-TECHNICS". The logo consists of the letters "nc" in a stylized, interconnected design, enclosed within a thin black circle. Above the "c", there is a small upward-pointing arrow in a pinkish-red color. Below the circle, the words "NEWCLIP-TECHNICS" are written in a simple, sans-serif font, with a noticeable space between "NEWCLIP" and "TECHNICS".
510 (k) Summary for the Activmotion S DTO range
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Activmotion S DTO range.
Summary preparation date: December 13, 2021
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: | Activmotion S DTO |
|---|---|
| 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 fixatio |
| appliances and accessories. (21 CFR part. 888.3030) | |
| (Primary) | |
| Smooth or threaded metallic bone fixation fastener.(2 | |
| CFR part. 888.3040) |
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Image /page/4/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo features a circle with the letters "nct" inside. The "t" in "nct" has an arrow pointing upwards. The words "NEWCLIP-TECHNICS" are written in capital letters below the circle. The letters are gray.
3. Primary predicate or legally marketed devices which are substantially equivalent:
- TIBIAXYS System by NEWDEAL (Integra Lifesciences) (K073375) ●
Secondary predicate or legally marketed devices which are substantially equivalent:
- · LOQTEQ Small Fragment set by AAP IMPLANTATE AG (K113652)
Reference device:
- · Activ ankle (K143061, K173641) of Newclip Technics.
-
- Description of the device: The Activmotion S DTO range consists of plates and screws designed for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
The Activmotion S DTO range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use.
- CP Titanium (conform to ASTM F67 and ISO Materials: 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).
- The implants of the Activmotion S DTO range are Function: intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
5. Substantial equivalence claimed to predicate devices:
The Activmotion S DTO range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
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Image /page/5/Picture/1 description: The image shows the logo for Newclip Technics. The logo consists of a circle with the letters "nct" inside. The "t" in "nct" is stylized with an upward-pointing arrow. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.
6. Indications for use:
The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
7. Summary of the technological characteristics compared to predicate
Material
The Activmotion S DTO range uses the same material as the predicate devices.
Design
The Activmotion S DTO range and the predicates are equivalent in terms of shape, material, and operating principles.
Sizes
The Activmotion S DTO range and the predicates are equivalent in their dimensions.
8. Non-clinical Test Summary:
The following tests were conducted:
-
Engineering analysis and comparative 4-point-bending tests in static and dvnamic condition were conducted to compare the bending strength of the subject device plates to the predicates. Static and dynamic tests were conducted according to according to ASTM F382.
-
Engineering analysis: torsional, driving torque, and pullout tests according to ASTM F543 were performed on the subject screws.
-
Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Activmotion S DTO range is as safe and as effective as the predicates.
9. Clinical Test Summary:
No clinical studies were performed.
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Image /page/6/Picture/0 description: The image shows the logo for Newclip-Technics. The logo consists of the letters 'nct' inside of a circle. The 't' in 'nct' is colored in pink and has an arrow pointing upwards. Below the circle, the words 'NEWCLIP-TECHNICS' are written in a sans-serif font.
10. Conclusions Non-clinical and clinical:
Based on the indications for use, technological characteristics, and the summary of data submitted, Newclip Technics determined that the Activmotion S DTO range is equivalent to the predicate devices listed above.