(57 days)
No
The summary describes a mechanical implant system (plates and screws) for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "implants of the Alians Clavicle range" used for "fixation of fractures, mal-unions and osteotomies of the clavicle in adults," which directly addresses and treats a medical condition.
No
The device is an implant for fixing clavicle fractures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of plates and screws, which are hardware implants.
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 Alians Clavicle range consists of plates and screws designed for the fixation of fractures, mal-unions, and osteotomies of the clavicle. These are physical implants used within the body to stabilize bone.
- Intended Use: The intended use is for the fixation of bone issues, not for testing or analyzing biological samples.
The description clearly indicates this is a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions and osteotomies of the clavicle in adults.
Product codes
HRS, HWC
Device Description
The Alians Clavicle range consists of plates and screws designed for fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults.
The implants of the Alians Clavicle 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 Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial C) contain implants and instruments provided sterile by gamma sterilization. The Initial C kits contain implants (1 plate + screws), and instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle
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
No clinical studies were performed. Engineering analyses have been conducted in comparison with Clavicle Locking Plating System of Newclip Technics (K100944). LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NEWCLIP TECHNICS Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
March 30, 2017
Re: K170310
Trade/Device Name: Alians Clavicle 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: January 26, 2017 Received: February 1, 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
1
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 the quality systems (QS) 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.
Mark N. Melkerson -S
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
Alians Clavicle range
Indications for Use (Describe)
The implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions and osteotomies of the clavicle in adults.
Type of Use (Select one or both, as applicable)
ا 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/0 description: The image shows the logo for NEWCLIP-TECHNICS. The logo consists of the letters "nct" inside of a circle, with the "t" in "nct" being a different color. Below the circle is the text "NEWCLIP-TECHNICS".
510 (k) Summary for the ALIANS CLAVICLE range 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) Summary is submitted for the Alians Clavicle range.
Summary preparation date: January 24, 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: | Alians Clavicle range |
| Common Name: | Fracture fixation plates and screws |
| 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) |
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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" in a circle, with a red arrow pointing upwards replacing the right side of the letter "t". Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
3. Primary predicate:
- Clavicle Locking Plating System of Newclip Technics (K100944) .
Additional predicate:
- Congruent Bone Plate System of Acumed (K102998) .
Reference Device:
- Activ Ankle Locking plate System of Newclip Technics (K143061) .
| 4. Description of the device: | The Alians Clavicle range consists of plates
and screws designed for fixation of
fractures, mal-unions, non-unions and
osteotomies of the clavicle in adults.
The implants of the Alians Clavicle 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 Alians Clavicle
range will be provided non sterile for
sterilization by health care professionals
prior to use.
Single use kits (Initial C) contain implants
and instruments provided sterile by gamma
sterilization. The Initial C kits contain
implants (1 plate + screws), and
instrumentation. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM
F 136 and/or ISO 5832-3). |
| Function: | The implants of Alians Clavicle range are
indicated for fixation of fractures, mal-
unions, non-unions and osteotomies of the
clavicle in adults. |
5
Image /page/5/Picture/0 description: The image shows a logo for a company called "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nct" inside. The "t" has an upward-pointing arrow as part of the letter. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.
5. Substantial equivalence claimed to predicate devices:
The Alians Clavicle 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 implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults.
7. Non-clinical Test Summary:
- . Engineering analyses have been conducted in comparison with Clavicle Locking Plating System of Newclip Technics (K100944).
- LAL testing was performed to demonstrate that the subject device meets • the endotoxin limit of