(53 days)
Not Found
No
The summary describes standard mechanical bone plates and screws and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is a medical implant (bone plates and screws) used for the fixation of fractures, which is a therapeutic intervention.
No
Explanation: The device is described as Locking Bone Plates and Screws, intended for fixation of fractures. Its function is to physically support bones, not to diagnose medical conditions, analyze biological signals, or provide information about a patient's health status.
No
The device description explicitly states the product contains physical components: locking plates, locking screws, and instruments. These are hardware components, not software.
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 for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that these are "Locking Bone Plates and Screws" used for "internal fixation of bones" and "fix the plates on the bones" during surgery. These are implanted devices used directly on the patient's anatomy.
- Intended Use: The intended use is for "fixation of fractures" in specific bones. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided describes a surgical implant and associated instruments, which fall under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
Locking Bone Plates and Screws are intended 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 proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.
The bone plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.
Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.
These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.
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 F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws.
ANSI/AAMI/ISO17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
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
Section III 510(k) Summary Premarket Notification 510(k) Submission
Project #:M0042013Aa
Section Ill 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.
K130340 The assigned 510(k) Number:
- Date of Submission: 01/27/2013 1.
-
- Sponsor
Weigao Orthopaedic Device Co., Ltd. No 26 Xiangjiang Road, Tourist Resorts, Weihai, Shandong, 264203, China
Establishment Registration Number: 3006639944
Contact Person: Han Wang Position: Quality & Technique Manager Tel: +86-631-5788966 Fax: +86-631-5660958 Email: wanghan@wegortho.com
3, Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023. Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Proposed Device Identification
Proposed Device Name: Locking Bone Plates and Screws
Classification Name: Plate, Fixation, Bone Common Name: Bone Plates Class: Class II Product Code: HRS Regulation Number: 21 CFR 888.3030
1
K130340 page 2 of 4
Premarket Notification 510(k) Submission
Section III 510(k) Summary
Project #:M0042013Aa
Review Panel: Orthopedic
Classification Name: Screw. Fixation. Bone Common Name: Bone Screws Class: Class II Product Code: HWC Regulation Number: 21 CFR 888.3040 Review Panel: Orthopedic
Intended Use Statement:
Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for . fixation of fractures, including ulna, radius, humerus, femur and tibia.
- ను Predicate Device Identification
510(k) Number: K101400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd
510(k) Number: K100721 Product Name: Locking Bone Screw Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd
6. Device Description
The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.
The bone plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.
Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.
These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.
7 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:
III-2
. •
2
ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. ANSI/AAMI/ISO17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- Substantially Equivalent Comparison and Conclusion જે.
| ITEM | Proposed Device
Locking Bone Plates and Screws | Predicate Device |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | | Locking Compression Plate
K101400
Locking Bone Screw K100721 |
| Product Code | Plate: HRS
Screw: HWC | Same |
| Regulation No. | Plate: 21 CFR 888.3030
Screw: 21 CFR 888.3040 | Same |
| Class | Class II | Same |
| Regulation No. | Plate: 21 CFR 888.3030 | Same |
| Intended Use | Locking Bone Plates and Screws are
intended for adult patients with age above
21 as indicated for fixation of fractures,
including ulna, radius, humerus, femur and
tibia. | Similar |
| Sterilization | Method: Autoclave
SAL: 10⁻⁶ | Same |
- Table III-1 General and Safety Comparison
3
Premarket Notification 510(k) Submission
Section III 510(k) Summary
| ITEM | Proposed Device
Locking Bone Plates and Screws | Predicate Device
Locking Compression Plate
K101400
Locking Bone Screw K100721 |
|-----------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------|
| Physical Specifications - Locking Bone Plates | | |
| Number of Holes | 2-24 | Similar |
| Length | 26-312 mm | Similar |
| Thickness | 3.3 / 3.6 / 4.2 mm | Similar |
| Width | 11 / 12.5 / 13.5 mm | Similar |
| Material | Titanium conforms to ASTM F67-06 | Similar |
| Physical Specifications - Locking Bone Screws | | |
| Diameters | 3.5. 4.5, 5.0 | Similar |
| Lengths | 10~120mm | Same |
| Material | Ti6Al4V ELI conforms to ASTM
F136 | Same |
| Mechanical Performance | | |
| Test items for bone
plates | Static four point bending
Dynamic four point bending | Same |
| Test standard for bone
plates | ASTM F 382-99 | Same |
| Test items for bone
screws | Torsional properties
Driving torque
Pull-out test | Same |
| Test standard for bone
screws | ASTM F543-07 | Same |
Table III-2 Specifications and Performance Comparison
. Difference in intended use, and physical specifications between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device. Locking Bone Plates and Screws, is determined to be Substantially Equivalent (SE) to the predicate device, Locking Compression Plate (K101400), and Locking Bone Screw (K100721), in respect of safety and effectiveness.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Weigao Orthopaedic Device Co., Ltd. % Mid-Link Consulting Co., Ltd Ms. Diana Hong General Manager P.O. Box 237-023, 200237 Shanghai China
Letter dated: April 5, 2013
Re: K130340 Trade/Device Name: Locking Bone Plates and Screws 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: February 7. 2013 Received: February 19, 2013
Dear Ms. Hong:
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
5
Page 2 - Ms. Diana Hong
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
6
Section II Indications for Use
510(k) Number: K130340 Device Name: Locking Bone Plates and Screws
Indications for Use:
Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OR
OOVER-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
Elizabeth பூர்ลีที่ -S
Division of Orthopedic Devices