(94 days)
Not Found
No
The device description and performance studies focus on mechanical properties and geometric analysis of the hardware, with no mention of AI or ML.
Yes
The device is intended for the fixation of fractures and pseudarthrosis, which are therapeutic interventions for medical conditions.
No
The device is a plating system used for fixation of fractures and pseudarthrosis, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a plate, screws, and washers made of titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Activ Ankle Locking Plating System is a surgical implant (plates and screws) used to fix fractures and other issues in the fibula bone. It is used in the body, not to test samples from the body.
- Intended Use: The intended use is for the fixation of fractures and pseudarthrosis of the fibula and for syndesmotic repair. This is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical implant used for orthopedic fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair in adults.
Product codes
HRS, HWC
Device Description
The Activ Ankle Locking Plating System consists of a plate with many screws as holes (slots) designed for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults. The plates and screws are manufactured from titanium alloy and color anodized. Washers are also available for use with syndesmosis screws.
The Activ Ankle Locking Plating System 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 Activ Ankle Locking Plating System are indicated for fixation of fractures, osteotomies and pseudarthrosis of the distal and the diaphyseal fibula in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal and the diaphyseal fibula
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
Non-clinical Test Summary:
The following tests were conducted:
- Comparative fatigue compression tests.
- Comparative static tests.
- Geometric analysis of the subject and predicate screws
Clinical Test Summary:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K000684, K073460, K131093, K120854
Reference Device(s)
Not Found
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.
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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 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
NEWCLIP TECHNICS % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K143061
Trade/Device Name: Activ Ankle Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 22, 2014 Received: October 24, 2014
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
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Page 2 - J.D. Webb
(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.
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,
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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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143061
Device Name Activ Ankle Locking Plating System
Indications for Use (Describe)
The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair 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 a logo for a company called NEWCLIP-TECHNICS. The logo consists of a circle with the letters "nc" inside, and a red arrow pointing upwards. The words "NEWCLIP-TECHNICS" are written in a sans-serif font below the circle. The logo is simple and modern, and the red arrow adds a touch of color and dynamism.
510 (k) Summary for the Activ Ankle Locking Plating System 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 Locking Plating System.
Summary preparation date: January 26, 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: | Activ Ankle Locking Plating System | |
| Common Name: | Plates for fibula fractures, osteotomies and | |
| pseudarthrosis | ||
| Screws and washers associated | ||
| Instrumentation associated | ||
| Product code: | HRS/HWC | |
| Classification Name: | Plate, Fixation, Bone | |
| (21 CFR part. 888.3030) | ||
| Screw, Fixation, Bone | ||
| (21 CFR part. 888.3040) |
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Image /page/4/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" has an upward-pointing arrow as the vertical bar. The word "NEWCLIP-TECHNICS" is written in all caps below the circle.
3. Predicate or legally marketed devices which are substantially equivalent:
- The Synthes Small Fragment Dynamic Compression Locking (DCL) System . of Synthes (K000684),
- The Synthes 2.7mm/3.5mm LCP Distal Fibula Plates of Synthes (K073460), .
- The Ortholoc® 3Di Ankle Plating System of Wright Medical Technology, . Inc. (K131093),
- The Synthes Variable Angle LCP Ankle Trauma System (K120854). •
| 4. Description of the device: | The Activ Ankle Locking Plating System
consists of a plate with many screws as
holes (slots) designed for fixation of
fractures, osteotomies and pseudarthrosis
of the distal and diaphyseal fibula and for
the syndesmotic repair in adults. The plates
and screws are manufactured from
titanium alloy and color anodized.
Washers are also available for use with
syndesmosis screws. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Activ Ankle Locking Plating System
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 Activ Ankle Locking
Plating System are indicated for fixation of
fractures, osteotomies and pseudarthrosis
of the distal and the diaphyseal fibula in
adults. |
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Image /page/5/Picture/0 description: The image shows a logo for New Clip-Technics. The logo consists of the letters "nct" inside of a circle. The "t" in "nct" has an upward-pointing arrow above it and is a different color than the "nc". Below the circle, the words "NEW CLIP-TECHNICS" are written in all caps.
5. Substantial equivalence claimed to predicate devices:
The Activ Ankle Locking Plating System is substantially equivalent to the Synthes Small Fragment Dynamic Compression Locking (DCL) System of Synthes (K000684), the Ortholoc® 3Di Ankle Plating System from Wright Medical Technology, Inc. (K131093), the Synthes 2.7mm/3.5mm LCP Distal Fibula Plates of Synthes (K073460), and The Synthes Variable Angle LCP Ankle Trauma System (K120854) in terms of intended use, design, materials used, mechanical safety and performance.
6. Intended use:
The Activ Ankle Locking Plating System is indicated for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative fatigue compression tests. .
- Comparative static tests. .
- Geometric analysis of the subject and predicate screws .
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
The Activ Ankle Locking Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.