(239 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of plates and screws for fracture fixation, with no mention of AI/ML or related concepts.
Yes.
The device is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna, which restores function to an injured body part.
No
This device is designed for the fixation of fractures and osteotomies, which is a therapeutic function, not a diagnostic one. It does not perform any diagnostic measurements or provide diagnostic information.
No
The device description explicitly states it consists of plates and screws made of titanium alloy, 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 the "fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "plates and screws" made of titanium alloy, which are implants used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is an implant used for surgical repair.
N/A
Intended Use / Indications for Use
The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The implants of the Alians Elbow Locking Plating System 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 Elbow Locking Plating System range will be provided non sterile for sterilization by health care professionals prior to use or sterile.
Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3). The implants of the Alians Elbow Locking Plating System are intended for the fixation of fractures and osteotomies of the distal humerus and the proximal ulna in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus and proximal ulna
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)
Engineering analysis was performed to evaluate the bending strength and bending stiffness of the subject device plates compared to predicates.
Engineering analysis was performed to evaluate the removable support compared to 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.
K152289, K102998, K912936, K103408
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.
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January 4, 2018
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K171372
Trade/Device Name: Alians Elbow Locking Plating System 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 4, 2017 Received: December 5, 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) K171372
Device Name
Alians Elbow Locking Plating System
Indications for Use (Describe)
The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K171372 Page 1/3
Image /page/3/Picture/1 description: The image shows the logo for Newclip-Technics. The logo consists of a circle with the letters "nct" inside. A red arrow points upwards to the right of the "t". Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
510 (k) Summary for the ALIANS ELBOW LOCKING 4. PLATING SYSTEM
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Elbow Locking Plating System.
Summary preparation date: March 15, 2017
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: | Alians Elbow Locking Plating System |
|---|---|
| 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/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nct" inside. The "t" is colored in red, and the rest of the letters are black. The words "NEWCLIP-TECHNICS" are written in a sans-serif font below the circle.
3. Primary predicate or legally marketed devices which are substantially equivalent:
- . Alians Elbow Locking Plating System of Newclip Technics (K152289)
Secondary predicate or legally marketed devices which are substantially equivalent:
- 3.5 Mm LCP Distal Humerus System of Synthes (K102998) .
- May Humerus Plate of Turnkey Integration USA (K912936) •
- Anatomic Locked Plating System Extra Long Plate Line Extension of . Synthes (K103408)
- The Alians Elbow Locking Plating system 4. Description of the device: consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The implants of the Alians Elbow Locking Plating System 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 Elbow Locking Plating System range will be provided non sterile for sterilization by health care professionals prior to use or sterile.
of fractures and osteotomies of the distal humerus and the proximal ulna in adults.
Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3). The implants of the Alians Elbow Locking Function: Plating System are intended for the fixation
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Image /page/5/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nct" inside. The "t" in "nct" has an arrow pointing upwards. The words "NEWCLIP-TECHNICS" are written in all caps below the circle.
5. Substantial equivalence claimed to predicate devices:
The Alians Elbow Locking Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
6. Indications for use:
The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
7. Non-clinical Test Summary:
Engineering analysis was performed to evaluate the bending strength and bending stiffness of the subject device plates compared to predicates.
Engineering analysis was performed to evaluate the removable support compared to predicates.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip considers the Alians Elbow Locking Plating System 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.