(87 days)
Not Found
No
The summary describes a system of 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 consists of plates and screws intended for the treatment of hand and forearm fractures, osteotomies, and arthrodeses, which are therapeutic medical interventions.
No
The device, Alians Fragment Specific range, consists of plates and screws intended for surgical fixation of hand and forearm fractures, osteotomies, and arthrodeses. It is an implantable device used for treatment, not for diagnosing a condition.
No
The device description explicitly states it consists of plates and screws, 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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Alians Fragment Specific range consists of implants (plates and screws) and instruments used for surgical procedures on the hand and forearm. These are physical devices inserted into or used on the body, not used to test samples outside the body.
- Intended Use: The intended use is for treating fractures, osteotomies, and arthrodeses through surgical intervention, not for diagnostic testing of biological samples.
The information provided clearly describes a surgical implant and instrument system, which falls under the category of medical devices used for treatment, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.
Product codes
HRS, HWC
Device Description
The Alians Fragment Specific range consists of plates and screws designed for hand and forearm fractures, osteotomies and arthrodeses in adults.
The implants of the Alians Fragment Specific 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 Fragment Specific range will be provided non sterile for sterilization by health care professionals prior to use.
Single use kits (Initial FS) contain implants and instruments provided sterile by gamma sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and forearm
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 tests were conducted:
- Comparative static bend test. (ASTM F382)
- Comparative fatigue bend test. (ASTM F382)
- Torsional test (ASTM F543)
- Insertion and removal test (ASTM F543)
- Pull-out tests. (ASTM F543)
- Endotoxins testing was performed using LAL quantitative kinetic chromogenic method.
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K142906, K060041, K102694, K130774, K161448, K143061
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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Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2017
Newclip Technics % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K170843
Trade/Device Name: Alians Fragment Specific 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: March 17, 2017 Received: March 21, 2017
Dear Mr. 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
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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 (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,
Vincent J. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Alians Fragment Specific
Indications for Use (Describe)
The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses 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 the logo for 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 is the text "NEWCLIP-TECHNICS" in a sans-serif font.
510 (k) Summary for the ALIANS FRAGMENT SPECIFIC 4. range
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Fragment Specific range.
Summary preparation date: January 10, 2017
1. Submitter:
Contact Person:
J.D. Webb NEWCLIP TECHNICS P.A. de la Lande Saint Martin The OrthoMedix Group, Inc. 45 rue des Garottières 1001 Oakwood Blvd Round Rock, TX 78681 F-44115 Haute-Goulaine - France Telephone: (33) 2 28 21 37 12 Telephone: 512-388-0199
- Alians Fragment Specific 2. Trade name: Fracture fixation plates and screws Common Name: 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 shows the logo for 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 and is colored in red. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
3. Primary predicate or legally marketed devices which are substantially equivalent:
- . APTUS® Wrist 2.5 System of Medartis (K142906)
Secondary predicate or legally marketed devices which are substantially equivalent:
- Trimed Bone Plates of Trimed (K060041) .
- 2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), .
- Universal Distal Radius System of Newclip Technics (K130774). •
- Footmotion Plating System of Newclip (K161448) .
- Activ Ankle Locking Plating System of Newclip (K143061) .
| 4. Description of the device: | The Alians Fragment Specific range
consists of plates and screws designed for
hand and forearm fractures, osteotomies
and arthrodeses in adults. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The implants of the Alians Fragment
Specific 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 Fragment
Specific range will be provided non sterile
for sterilization by health care professionals
prior to use.
Single use kits (Initial FS) contain implants
and instruments provided sterile by gamma
sterilization. |
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM
F136 and ISO 5832-3).
CP-titanium (conform to ASTM F67 and
ISO 5832-2).
Stainless steel and other instrument
materials |
| Function: | The implants of Alians Fragment Specific
range are indicated for hand and forearm
fractures, osteotomies and arthrodeses in
adults. |
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Image /page/5/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 with an upward-pointing arrow. Below the circle, the words "NEWCLIP-TECHNICS" are written in a sans-serif font.
5. Substantial equivalence claimed to predicate devices:
The Alians Fragment Specific 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 Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative static bend test. (ASTM F382) ●
- Comparative fatigue bend test. (ASTM F382) .
- . Torsional test (ASTM F543)
- Insertion and removal test (ASTM F543) .
- Pull-out tests. (ASTM F543) •
- Endotoxins testing was performed using LAL quantitative kinetic . chromogenic method.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip considers the Alians Fragment Specific 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.