(81 days)
No
The device description and performance studies focus on the mechanical properties and comparison to predicate devices, with no mention of AI or ML.
Yes.
The device is intended for knee osteotomy, which is a therapeutic procedure involving surgical intervention to realign the knee.
No
The device description indicates it is a range of pre-contoured plates and screws used for knee osteotomy, an orthopedic surgical procedure, rather than for diagnosing a condition.
No
The device description explicitly states it consists of physical implants (plates and screws) and instruments, which are 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 "knee osteotomy in adults," which is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "pre-contoured tibial and femoral plates and screws," which are implants used to fix bones during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Activmotion range is intended for knee osteotomy in adults.
Product codes
HRS, HWC
Device Description
The Activmotion range consists of pre-contoured tibial and femoral plates and screws in various sizes designed for knee osteotomy in adults. The plates and screws are manufactured from titanium alloy and color anodized. The implants of the Activmotion 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 Activmotion range will be provided non sterile for sterilization by health care professionals prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Non-clinical Test Summary:
- Engineering analysis was conducted to compare the bending strength and bending stiffness of the subject device plates to the predicates.
- ASTM F543 torsional testing was performed on the subject screws. Engineering analysis was conducted to compare the axial pull-out strength.
- Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Activmotion range is as safe and as effective as the predicates.
Clinical Test Summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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February 27, 2018
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K173746
Trade/Device Name: Activmotion Range 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: December 5, 2017 Received: December 8, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 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 mediation-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
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Indications for Use
510(k) Number (if known) K173746
Device Name
Activmotion Range
Indications for Use (Describe)
The Activmotion range is intended for knee osteotomy 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) |
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Image /page/3/Picture/1 description: The image shows a logo for "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nc" inside. The "t" in "nc" is stylized as an upward-pointing arrow and is colored in pink. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.
510(k) Summary for the ACTIVMOTION range 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Activmotion range.
Summary preparation date: December 01, 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: | Activmotion range |
| 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) |
3. Primary predicate or legally marketed devices which are substantially equivalent:
- Depuy Synthes Tomofix Osteotomy System of Synthes (K141796) .
Secondary predicate or legally marketed devices which are substantially equivalent:
- High Tibial Osteotomy System of Newclip Technics (K141548) •
- Anthem™ Fracture System of Globus Medical Inc (K163361) .
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Page 2/3 K173746
Image /page/4/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters 'nct' in a circle, with a red 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, with a clear emphasis on the company name.
Reference predicate :
- Alians Elbow Locking Plating System of Newclip Technics (K152289) .
| 4. Description of the device: | The Activmotion range consists of pre-
contoured tibial and femoral plates and
screws in various sizes designed for knee
osteotomy in adults. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The plates and screws are manufactured
from titanium alloy and color anodized. |
| | The implants of the Activmotion 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 Activmotion range
will be provided non sterile for sterilization
by health care professionals prior to use. |
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform to
ASTM F136 and ISO 5832-3). |
| Function: | The implants of Activmotion range are
intended for knee osteotomy in adults. |
5. Substantial equivalence claimed to predicate devices:
The Activmotion range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
6. Indications for use:
The Activmotion range is intended for knee osteotomy in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
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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" is colored in red and has an arrow pointing upwards. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.
-
Engineering analysis was conducted to compare the bending strength and bending stiffness of the subject device plates to the predicates.
-
ASTM F543 torsional testing was performed on the subject screws.
Engineering analysis was conducted to compare the axial pull-out strength.
- Endotoxin testing is performed using LAL quantitative kinetic chromogenic method.
The analysis showed that the Activmotion range is as safe and as effective as the predicates.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip considers the Activmotion 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.