(370 days)
No
The device description and performance studies focus on the mechanical properties and design of plates and screws for fracture fixation, with no mention of AI or ML technologies.
No.
The device is described as a plating system intended for the fixation of fractures and osteotomies, which acts as a support structure rather than directly treating or curing a disease or condition.
No
The device is described as a "Plating System" intended for the "fixation of fractures and osteotomies." This indicates that it is a therapeutic device used to treat or repair bone structures, not to diagnose a condition.
No
The device description explicitly states it consists of plates and screws made from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Alians Elbow Locking Plating System Function: The Alians Elbow Locking Plating System is a surgical implant used to physically fix fractures and osteotomies in bones (distal humerus and proximal ulna). It is a mechanical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states "fixation of fractures and ostectornies of the distal humerus and proximal ulna in adults." This is a surgical intervention, not a diagnostic test.
The device description and intended use clearly indicate that this is a surgical implant for orthopedic procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Alians Elbow Locking Plating System is intended for the fixation of fractures and ostectornies 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 plates and screws are manufactured from titanium alloy and are color anodized.
The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation.
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)
Non-clinical Test Summary:
The following tests were conducted:
- Comparative dynamic bending tests .
- Comparative static bending tests .
- Torsional tests •
- Engineering analyses .
Clinical Test Summary:
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.
K000684, K011335, K974289, K993106, K143061
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three faces in profile, all facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
NEWCLIP TECHNICS % J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K152289
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: July 7, 2016 Received: July 15, 2016
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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)
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 ostectornies of the distal humerus and proximal ulna 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)
3
Image /page/3/Picture/0 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 below the circle in a sans-serif font.
510 (k) summary for the Alians Elbow 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 Alians Elbow Locking Plating System.
Summary preparation date: August 1, 2016
| 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 Elbow Locking Plating System |
| Common Name: | Fracture fixation plates and screws |
| Product code: | HRS/HWC |
| Classification Name: | Plate, Fixation, Bone |
| (21 CFR part. 888.3030) | |
| Screw, Fixation, Bone | |
| (21 CFR part. 888.3040) |
3. Primary predicate or legally marketed devices which are substantially equivalent:
- The Synthes Variable Angle LCP Elbow System (medial and posterolateral . distal humerus plates) of Synthes (K120070 and K120717)
4
1
Secondary predicate or legally marketed devices which are substantially equivalent:
- The Synthes Small Fragment Dynamic Compression Locking (DCL) . System (K000684)
- The Synthes One Third DCL Plate (same as DePuy) (K011335) •
- The Epi-union Plating System of Stryker (K974289) .
- . The TC-100 Screw & Plating System (K993106)
- The Activ Ankle Locking Plating system of Newclip Technics (K143061) .
| 4. Description of the device: | 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 plates and screws are manufactured from titanium alloy and are color anodized.
The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and/or ISO 5832-3). |
| Function: | 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 |
5. Substantial equivalence claimed to predicate devices:
ulna in adults.
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.
5
Image /page/5/Picture/0 description: The image shows a logo for NEWCLIP-TECHNICS. The logo consists of a circle with the letters "nct" inside. The "t" is colored in pink. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.
6. Intended 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:
The following tests were conducted:
- Comparative dynamic bending tests .
- Comparative static bending tests .
- Torsional tests •
- Engineering analyses .
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.