The Metallic Locking Bone Plate and Screw System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

Device Description

The proposed device, Metallic Locking Bone Plate and Screw System 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 made of 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the "Metallic Locking Bone Plate and Screw System." It details the device's characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device meets design specifications and is substantially equivalent to the predicate device based on bench testing. The acceptance criteria are defined by industry standards for metallic bone fixation devices.

Acceptance Criteria (Standard)	Reported Device Performance (Test)
For Metallic Bone Plates (ASTM F382-99 (2008))
Static four-point bending strength	Static four-point bending test conducted
Dynamic four-point bending endurance	Dynamic four-point bending test conducted
For Metallic Medical Bone Screws (ASTM F543-07)
Torsional properties (e.g., torque to failure)	Torsional properties test conducted
Driving torque characteristics (e.g., maximum driving torque)	Driving torque test conducted
Pull-out strength	Pull-out test conducted

Note: The document explicitly states "No clinical performance testing" and "No clinical studies to support substantial equivalence." The "Reported Device Performance" column indicates that these tests were conducted and the conclusion is that the device "should perform as intended." Specific numerical results or statistical analyses from these tests are not provided in this summary document. The acceptance criteria for these tests are the requirements outlined in the ASTM standards themselves.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size used for the bench tests (e.g., how many plates or screws were tested for each performance metric).
Data Provenance: The tests are bench tests, not clinical studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for patient data. The tests were likely conducted by the manufacturer, Changzhou Dingjian Medical Appliance Co., Ltd., in China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This question is not applicable to the context of this document. The "ground truth" for material and mechanical performance is established by the specifications in the ASTM standards and the physical properties of the device, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

This is not applicable as the test set involves bench testing against predefined engineering standards, not human interpretation or clinical adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing" and "The subject of this premarket submission, metallic locking bone plate system, does not require clinical studies to support substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is a physical medical implant (bone plate and screw system), not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation in this submission is the mechanical and material specifications outlined in the referenced ASTM F382 (for plates) and ASTM F543 (for screws) standards. Compliance with these established engineering standards serves as the basis for performance evaluation for non-clinical aspects.

8. The Sample Size for the Training Set:

This question is not applicable. There is no concept of a "training set" for a physical medical device in this type of premarket notification for substantial equivalence based on bench testing.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

June 5, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Changzhou Dingjian Medical Appliance Company, Ltd % Mr. Mike Gu OSMUNDA Medical Device Consulting Company, Ltd 7th Floor Jingui Business Buildng No. 982 Cogyuan Road, Baiyun District Guangzhou, 510420 Guangdong China

Re: K143002/S003 Trade/Device Name: Metallic Locking Bone Plate and Screw 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: May 25, 2015 Received: May 28, 2015

Dear Mr. Mike 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, 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

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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

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143002

Device Name Metallic Locking Bone Plate and Screw System

Indications for Use (Describe)

The Metallic Locking Bone Plate and Screws System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

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)

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Image /page/3/Picture/0 description: The image contains the logo for D&J medical. The logo consists of a stylized graphic of three concentric arcs with circles at the ends, colored in shades of green and teal. To the right of the graphic, the text "D&J medical" is written in green. Below the text, there are three Chinese characters in gray.

Premarket Notification Submission_ Metallic Locking Bone Plate and Screw System

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: SUBMITTER l.

Changzhou Dingjian Medical Appliance Co., Ltd.

No. 19 Juxiang Road

Wujin Economic Development Zone

Changzhou, Jiangsu Province, 213149, China

Mike Gu Primary Contact Person:

Regulatory Affairs Manager

OSMUNDA Medical Device Consulting Co., Ltd

Tel: (+86) 20-6232 1333

Fax: (+86) 20-8633 0253

Secondary Contact Person: Li Qingsong

Changzhou Dingjian Medical Appliance Co., Ltd.

Tel: 0086-13584330156

Fax: 0086-519-89603573

Date Prepared:	April 13, 2015
DEVICEII.
Name of Device:	Metallic Locking Bone Plate and Screw System
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:	==============================================================================================================================================================================

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Image /page/4/Picture/0 description: The image shows the logo for D&J medical. The logo consists of a teal and light green graphic on the left, followed by the text "D&J medical" in teal and light green. Below the text are four Chinese characters in gray.

market Notification Submission_ Metallic Locking Bone Plate and Screw System

Product Code: HRS and HWC

lll. PREDICATE DEVICE

Locking Bone Plates and Screws K130340;

Spacer K123918;

These predicates have not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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 System are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Metallic Locking Bone Plate and Screw System employs the same technology as its predicate devices K130340 and K123918.

The Metallic Locking Bone Plate and Screw System 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 nonlocking 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.

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Image /page/5/Picture/0 description: The image contains a logo for D&J medical. The logo consists of a teal and light green circular design on the left, followed by the text "D&J medical" in teal and light green. Below the text, there are three Chinese characters in gray. The logo appears to be for a medical practice or company.

Specification	Predicate Device	Proposed Device
	Locking Bone Plates and Screws K130340	Metallic locking bone plate andscrew system
Manufacturer	Weigao Orthopaedic Device Co.,Ltd.	Changzhou Dingjian MedicalAppliance Co., Ltd.
Class	II	II
Product Code	Plate: HRS; Screw: HWC	Plate: HRS; Screw: HWC
Regulation Number	Plate: 21CFR 888.3030	Plate: 21CFR 888.3030
	Screw: 21CFR 888.3040	Screw: 21CFR 888.3040
Intended Use	Locking bone plates and screws areintended for adult patients with ageabove 21 as indicated for fixation offracture.	Metallic locking bone plate andscrew systemis intended for adultpatients with age above 21 asindicated for fixation of fracture.
Indications for Use	Bone fracture in ulna, radius,humerus, femur and tibia	Bone fracture in ulna, radius,humerus, femur and tibia
Patient Population	Adult patients of age above 21	Adult patients of age above 21
Prescription/OTC Use	Prescription use	Prescription use
MechanicalPerformance	FOR PLATES: ASTM F 382-99FOR SCREWS: ASTM F543-07	FOR PLATES: ASTM F 382-99(2008)FOR SCREWS: ASTM F543-07
Materials	PLATES: titanium which conformsto ASTM F67Screw: Titanium alloy (TiAl4V ELI)which conforms to ASTM F136	PLATES: titanium which conformsto ASTM F67Screw: Titanium alloy (TiAl4V ELI)which conforms to ASTM F136
Biocompatibility	PLATES: titanium which conformsto ASTM F67Screw: Titanium alloy (TiAl4V ELI)which conforms to ASTM F136	PLATES: titanium which conformsto ASTM F67Screw: Titanium alloy (TiAl4V ELI)which conforms to ASTM F136
Sterility	Provided as non-sterile, needsautoclave prior to use	Provided as non-sterile, needssteam sterilization prior to use
Test items for boneplates	Static four point bendingDynamic four point bending	Static four point bendingDynamic four point bending
Test items for bonescrews	Torsional propertiesDriving torquePull-out test	Torsional propertiesDriving torquePull-out test

510(k) Premarket Notification Submission_ Metallic Locking Bone Plate and Screw System

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Image /page/6/Picture/0 description: The image shows the logo for D&J medical. The logo consists of a stylized teal and light green graphic to the left, resembling three people holding hands in a circle. To the right of the graphic is the text "D&J medical" in teal and light green. Below the text are four gray Chinese characters.

emarket Notification Submission_ Metallic Locking Bone Plate and Screw System

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

No clinical performance testing:

Bench tests were conducted to verify that proposed device meets all design specifications as was substantially equivalence to the predicate device. The following bench testing was performed to support a determination of substantial equivalence:

ASTM F382 standard specification and test method for metallic bone plates, including the following items:

. Static four point bending
. Dynamic four point bending

ASTM F543 standard specification and test methods for metallic medical bone screw including the following item:

Torsional properties
Driving torque
Pullout test

Animal and clinical study

The subject of this premarket submission, metallic locking bone plate system, does not require clinical studies to support substantial equivalence.

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Image /page/7/Picture/0 description: The image contains the logo for D&J medical. The logo consists of a stylized graphic of three concentric arcs with circles at the ends, colored in shades of teal and light green. To the right of the graphic, the text "D&J medical" is displayed, with "D&J" in teal and "medical" in light green. Below the text, there are three Chinese characters in gray.

510(k) Premarket Notification Submission_ Metallic Locking Bone Plate and Screw System

VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the performance testing report demonstrate that the metallic locking bone plate system should perform as intended in the specified use conditions. Changzhou Dingjian Medical Appliance Co., Ltd., Inc considers the metallic locking bone plate system does not raise any new issues of safety or effectiveness.

Regulation Number and Section

§ 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.