(184 days)
Not Found
No
The 510(k) summary describes a standard orthopedic implant system (plates and screws) and does not mention any AI or ML components or functionalities. The performance studies are bench tests comparing mechanical properties.
Yes.
Explanation: The device is intended for the fixation of fractures in various bones, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation:
The device is a Locking Compression Plate System designed for fixation of fractures. Its purpose is to physically stabilize bones, not to diagnose medical conditions.
No
The device description explicitly states it consists of plates and screws made of titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures" in bones (ulna, radius, humerus, femur, and tibia). 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, designed to be implanted surgically.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
This device is clearly an implantable surgical device used for orthopedic procedures, not for analyzing biological samples in a lab.
N/A
Intended Use / Indications for Use
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Product codes
HRS, HWC
Device Description
The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual.
The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, humerus, femur and tibia
Indicated Patient Age Range
adult patients with age above 21
Intended User / Care Setting
Not Found
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
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ASTM F543-07 Standard Specification and Test Methods for Metallic Medical A Bone Screws, A ASTM F 382–99 (Reapproved 2008) Standard Specification and Test Method for Metallic Bone Plates, Standard Test A ASTM F897-02 (Reapproved 2007) Method for Measuring Fretting Corrosion of Osteosynthesis Plates and screws.
Key Metrics
Not Found
Predicate Device(s)
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.
0
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| Premarket Notification 510(k) Submission | Exhibit #3 510(k) Summary | Project #: 510k-G11Z |
|---|---|---|
| (K112798) |
Exhibit #3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K112798
-
- Date of Submission: March 12, 2012.
-
- Sponsor
Shanghai MicroPort Orthopedics Co., Ltd.
Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, Pudong new area, Shanghai 201318, P.R. China
Contact Person: Jason Ma
Position: Regulatory Affairs Manager
+86-21-38954600-631 Tel:
+86-21-38019063 Fax:
ypma@microport.com Email:
-
- Proposed Device Identification
Proposed Device Name: Locking compression plate system
- Proposed Device Identification
Classification name: Plate, Fixation, Bone
Classification: II
Product Code: HRS, HWC
Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040
Review Panel: Orthopedic
Intended Use Statement:
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
| Shanghai MicroPort Orthopedics Co., Ltd. | ||
|---|---|---|
| Rev.: C | Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, | |
| Pudong new area, Shanghai 201318, P.R.China |
113
1
| Premarket Notification 510(k) Submission
| (K112798) | Exhibit #3 510(k) Summary | Project #: 510k-G11Z |
|---|---|---|
| ------------------------------------------------------- | --------------------------- | ---------------------- |
-
- Predicate Device Identification
510(k) Number: K101400.
- Predicate Device Identification
Product Name: Locking Compression Plate.
510(k) Number: K100721.
Product Name: Locking Bone Screw.
5. Device Description
The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual.
The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.
| Component name | Specification |
|---|---|
| Locking compression plate | Holes number: 2~18, every 1 hole; 20, 24; |
| Length: 44~442mm; | |
| Locking screw | Diameter: 3.5, 5.0mm; |
| Length: 14~120mm. |
6. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F543-07 Standard Specification and Test Methods for Metallic Medical A Bone Screws
- A ASTM F 382–99 (Reapproved 2008) Standard Specification and Test Method for
| Shanghai MicroPort Orthopedics Co., Ltd. | ||
|---|---|---|
| Rev.: C | Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, | 2/3 |
| Pudong new area, Shanghai 201318, P.R.China |
2
| Premarket Notification 510(k) Submission
| (K112798) | Exhibit #3 510(k) Summary | Project #: 510k-G11Z |
|---|---|---|
Metallic Bone Plates
- Standard Test A ASTM F897-02 (Reapproved 2007) Method for Measuring Fretting Corrosion of Osteosynthesis Plates and screws
-
- Substantially Equivalent Conclusion
Both the proposed and predicate devices have same classification, intended use and materials. The main differences between the proposed and predicate devices are dimension specifications. Mechanical testing were performed on both devices, test results demonstrated that they have similar performances. Therefore the proposed device, Locking Compression Plate System, is determined to be Substantially Equivalent (SE) to the predicate device, Locking Compression Plate as cleared under K101400 and Locking Bone Screw as cleared under K100721, in respect to safety and effectiveness.
Rev.: C
Shanghai MicroPort Orthopedics Co., Ltd. Building 23, No. 588 Tianxiong Rd. Shanghai international medical zone, Pudong new area, Shanghai 201318, P.R.China
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wings and tail. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shanghai Microport Orthopedics Co., LTD % Mr. Jason Ma Building 23, No. 588 Tianxiong Road SIMZ Bio Business Park Shanghai, P.R. China, 201318
MAR 2 9 2012
Re: K112798
Trade/Device Name: Locking compression plate 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: March 7, 2012 Received: March 22, 2012
Dear Mr. Ma:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Jason Ma
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millenson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
page 1/1
Exhibit #3 Indications for Use Project #: 510k-G11Z Premarket Notification 510(k) Submission (K112798)
Exhibit #3 Indications for Use
510(k) Number: K112798
Device Name: Locking compression plate system
Indications for Use:
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
&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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Douglas
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112798
Rev.: B