(297 days)
No reference devices were used in this submission.
No
The summary describes a purely mechanical bone plate and screw system with no mention of software, algorithms, or data processing, which are prerequisites for AI/ML.
No
This device is for fixation of bone fractures, not for therapeutic treatment.
No
This device is a metallic locking bone plate and screw designed for the fixation of fractures, not for diagnosing conditions.
No
The device description explicitly states it is a metallic locking bone plate and screw, which are physical hardware components used for internal fixation of bone fractures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures" in various bones. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "metallic Locking Bone Plate and Screw" used for "internal fixation of bone fracture." This is a physical implant used to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information about a disease or condition. The performance studies focus on mechanical properties and biocompatibility, not diagnostic accuracy.
In summary, this device is a surgical implant used for treating bone fractures, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The metallic locking bone plate and screw are intents with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:
- ostcotomies, mal-unions, and non-unions;
- single, segmental, and comminuted fractures;
- normal bone density and osteopenic bone.
Product codes
HRS, HWC
Device Description
The proposed device, metallic Locking Bone Plate and Screw consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is manufactured with Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
Metallic Locking Bone Plate and Screw is a structure formed by locking plate (which has at least one taper-thread hole) and locking screw (which has a head of taper-thread). Wherein the metal locking plate is a fracture fixation device with threaded holes, When the screw is revolved tightened in the plate, the plate system becomes an angle-fixed device. Locking plate can have both locking and non-locking screw holes fitting with various types of screws (also known as locking compression plate). In practice, positioning a plurality of screws in the locking plate maintains fracture anatomical reduction, which restores physiological function after bone healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, humerus, femur, tibia, clavicle, and fibula
Indicated Patient Age Range
above 21
Intended User / Care Setting
healthcare provider
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
The following performance data were provided in support of the substantial equivalence determination:
- ASTM F382 - 99(2008) Standard Specification and Test Method for Metallic Bone Plates, bend testing;
- ASTM F543 - 13 Standard Specification and Test Methods for Metallic Medical Bone Screws metallic Bone Plates.
Biocompatibility testing:
Metallic Locking Bone Plate and Screw is made of pure titanium and Ti-6Al-4V, complying with the ASTM F1472 and ASTM F67; the materials have been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Due to the wellcharacterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F 981.
There is no Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.
Animal and clinical study: The subject of this premarket submission, metallic Locking Bone Plate and Screw, does not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K073159, K073432, K130108, K130009
Reference Device(s)
No reference devices were used in this submission.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with flowing lines suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
August 3, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Canwell Medical Company, Ltd % Mr. Mike Gu Osmunda Medical Device Consulting Company, Ltd. 7th Floor Jingui Business Building 982 Cogyuan Road, Baiyun District 510420 Guangzhou China
Re: K142943
Trade/Device Name: Metallic Locking Bone Plate and Screw 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 3, 2015 Received: July 6, 2015
Dear Mr. Gu,
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, labcling, 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
1
Page 2 - Mr. Mike Gu
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 (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); 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142943
Device Name Metallic Locking Bone Plate and Screw
Indications for Use (Describe)
The metallic locking bone plate and screw are intents with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:
-
ostcotomies, mal-unions, and non-unions;
-
single, segmental, and comminuted fractures;
-
normal bone density and osteopenic bone.
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
3
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4
Traditional 510(k) Submission_Metalic bone plate system
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: l. SUBMITTER
.
Canwell Medical Co., Ltd.
No. 466 South Xianhua Street, High-tech Industrail Zone, Jinhua, Zhejiang, 321016 P. R. of China
Primary Contact Person: Mike Gu
Regulatory Affairs Manager
OSMUNDA Medical Device Consulting Co., Ltd
Tel: (+86) 20-6232 1333
Fax: (+86) 20-8633 0253
Secondary Contact Person: Chen Hui
Regulatory Affairs Manager
Canwell Medical Co., Ltd.
Tel: +86-(0)579-8911-9235
Fax: +86-(0)579-8223-9558
September 30, 2014 Date Prepared:
DEVICE II.
| Name of Device: | Metallic Locking Bone Plate and Screw |
|---|---|
| Common/Usual Name: | Bone Fixation Plate and Bone Fixation Screw |
| Classification Names: | Plate, Fixation, Bone (21 CFR 888.3030) |
| Screw, Fixation, Bone (21 CFR 888.3040) | |
| Regulation Class: | II |
| Product Code: | HRS and HWC |
!!!. PREDICATE DEVICE
5
Traditional 510(k) Submission_Metalic bone plate system
Locking Bone Plates and Screws' predicate devices: K073159, K073432, K130108 and K130009;
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The proposed device, metallic Locking Bone Plate and Screw consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is manufactured with Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
V. INDICATIONS FOR USE
The metallic locking bone plate and screw are intended for adult patients with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:
- osteotomies, mal-unions, and non-unions
- single, segmental, and comminuted fractures
- normal bone density and osteopenic bone
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Metallic Locking Bone Plate and screw employ the same plate and screw technology as its predicate devices K073159, K073432, K130108 and K130009.
Metallic Locking Bone Plate and Screw is a structure formed by locking plate (which has at least one taper-thread hole) and locking screw (which has a head of taper-thread). Wherein the metal locking plate is a fracture fixation device with threaded holes, When the screw is revolved tightened in the plate, the plate system becomes an angle-fixed device. Locking plate can have both locking and non-locking screw holes fitting with various types of screws (also known as locking compression plate). In practice, positioning a plurality of screws in the locking plate maintains fracture anatomical reduction, which restores physiological function after bone healing.
2 / 3
6
Traditional 510(k) Submission Metalic bone plate system
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- . ASTM F382 - 99(2008) Standard Specification and Test Method for Metallic Bone Plates , bend testing;
- . ASTM F543 - 13 Standard Specification and Test Methods for Metallic Medical Bone Screws metallic Bone Plates.
Biocompatibility testing:
Metallic Locking Bone Plate and Screw is made of pure titanium and Ti-6Al-4V, complying with the ASTM F1472 and ASTM F67; the materials have been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Due to the wellcharacterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F 981
There is no Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
Animal and clinical study
The subject of this premarket submission, metallic Locking Bone Plate and Screw, does not require clinical studies to support substantial equivalence.
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the performance testing report demonstrate that the metallic Locking Bone Plate and Screw should perform as intended in the specified use conditions. Canwell Medical Co., Ltd. considers the metallic locking bone plate and screw do not raise any new issues of safety or effectiveness.