(52 days)
Not Found
No
The 510(k) summary describes a standard metallic bone plate and screw system for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical testing against established standards for bone plates and screws.
No
The device is a system of bone plates and screws used for the fixation of fractures, which is a structural support function rather than a therapeutic one. It facilitates the healing process but does not directly treat a disease or condition.
No
Explanation: The device is described as a "Metallic Locking Compression Bone Plates and Screws System" used for "fixation of fractures." This indicates it is a surgical implant designed to treat a condition by providing physical support and stability, rather than to diagnose a condition.
No
The device description explicitly states it contains metallic plates, screws, and instruments, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the device is a "Metallic Locking Compression Bone Plates and Screws System." This is a surgical implant used to fix bone fractures.
- Intended Use: The intended use is "for fixation of fractures, including ulna, radius, humerus, femur and tibia." This is a direct surgical intervention on the body, not an examination of a specimen outside the body.
The device described is a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
Metallic Locking Compression Bone Plates and Screws 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 (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Metallic Locking Compression Bone Plates and Screws System contains (1) locking compression plates (LCPs) with various specifications, (2) two kinds of screws with various specifications and (3) various specific instruments. Locking Compression Plates that made of Titanium. They have combi-holes. the threaded hole sections on the plates for locking screws provides ability to create fixed-angle constructs; the un-threaded hole sections for cortex screws allows utilization of familiar AO plating techniques. The limited-contact design of LCPs reduces plate-to-bone contact, thus limiting vascular trauma.The screws are available in locking screws and cortex screws. There are various instruments specific to the proposed device intend for completing the surgery.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical 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 a) Plates.
- ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. b)
Static and Dynamic Performance tested per ASTM F382. Torsional, Driving Torque and Pull out strength tested per ASTM F543.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 8 2013 K131759
Project #: M0152013Ad Section 3 510k Summary Premarket Notification 510(k) Submission
Section 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 Title 21, CFR Section 807.92.
The assigned 510(k) Number: J
-
3.1 Date of Submission
06/07/2013 -
3.2 Sponsor Identification
Tianjin Walkman Biomaterial Co., Ltd No. 19, Technology Road, Tianjin Tianyu Science and Technology Garden Jinghai East, Tianjin, P.R. China 301609
Establishment Registration Number: Not yet registered
Contact Person: Ms. Fengmei Ren Position: Management Representative Tel: +86-22-68660780 Fax: +86-22-68660776 Email: wm-rfm@126.com
- 3.3 Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1
K131759
Project #: M0152013Ad Section 3 510k Summary Premarket Notification 510(k) Submission
3.4 Proposed Devices Identification
Proposed Device Name: Metallic Locking Bone Plates and Metallic Locking Bone Screws
Regulatory Information of Plates: Classification Name: Plate, Fixation, Bone Common Name: Bone Plates Class: Class II Product Code: HRS Regulation Number: 21 CFR 888.3030 Review Panel: Orthopedic
Regulatory Information of Screws: 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:
Metallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
3.5 Device Description
Metallic Locking Compression Bone Plates and Screws System contains (1) locking compression plates (LCPs) with various specifications, (2) two kinds of screws with various specifications and (3) various specific instruments. Locking Compression Plates that made of Titanium. They have combi-holes. the threaded hole sections on the plates for locking screws provides ability to create fixed-angle constructs; the un-threaded hole sections for cortex screws allows utilization of familiar AO plating techniques. The limited-contact design of LCPs reduces plate-to-bone contact, thus limiting vascular trauma.The screws are available in locking screws and cortex screws. There are various instruments specific to the proposed device intend for completing the surgery.
2
Premarket Notification 510(k) Submission Section 3 510k Summary
Project #: M01 52013Ad
3.6 Predicate Device Identification
Predicate Device 1
.
510(k) Number K101400
Predicate Device Name Locking Compression Plate
Manufacturer Changzhou Orthmed Medical Instrument Co., Ltd
Predicate Device 2
. 510(k) Number K100721
Predicate Device Name . Locking Bone Screw
Manufacturer Changzhou Orthmed Medical Instrument Co., Ltd
Predicate Device 3
510(k) Number K073159
Predicate Device Name Trauson Bone Screw
Manufacturer Trauson (Jiangsu) Medical Instrument Co., Ltd
3
3.7 Non-Clinical Test Conclusion
Non clinical 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 a) Plates.
- ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. b)
- 3.8 Clinical Testing Conclusion
No clinical study is included in this submission.
- 3.9 Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device | Predicate Device
1 | Predicate Device
2 | Predicate Device
3 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HRS
HWC | HRS
/ | /
HWC | /
HWC |
| Regulation Number | 21 CFR 888.3030
21 CFR 888.3040 | 21 CFR 888.3030
/ | /
21 CFR 888.3040 | /
21 CFR 888.3040 |
| Intended Use | Metallic Locking
Compression Bone
Plate and Screw
System is intended for
adult patients with age
above 21 as indicated
for fixation of
fractures, including
ulna, radius, humerus,
femur and tibia. | Locking Compression
Plate can be used for
adult patients with age
above 21 as indicated
for fixation of
fractures, including
ulna, radius, humerus,
femur and tibia. | Locking Bone Screw
is indicated for bone
reconstruction,
osteotomy,
arthrodesis, joint
fusion, fracture repair,
and fracture fixation
of bones appropriate
for the size of the
device. | Trauson Bone Screw
is indicated for bone
reconstruction,
osteotomy.
arthrodesis, joint
fusion, fracture repair,
and fracture fixation
of bones appropriate
for the size of the
device. |
| Material | Plate: Titanium
Cortex Screw:
Titanium alloy
Locking Screw: | Plate: Titanium
/
/ | /
/
Locking Screw: | /
Cortex Screw:
Stainless Steel
/ |
Table 3-1 Comparison of Technology Characteristics
4
| Titanium alloy | Titanium alloy | |||
|---|---|---|---|---|
| How supplied | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Single Use | Yes | Yes | Yes | Yes |
| Sterile | Subject to steam | |||
| sterilized prior to use. | Subject to steam | |||
| sterilized prior to use. | Subject to steam | |||
| sterilized prior to use. | Subject to steam | |||
| sterilized prior to use. | ||||
| Performance | Static and Dynamic | |||
| Performance tested | ||||
| per ASTM F382 | ||||
| Torsional, Driving | ||||
| Torque and Pull out | ||||
| strength tested per | ||||
| ASTM F543. | Static and Dynamic | |||
| Performance tested | ||||
| per ASTM F382 | Torsional, Driving | |||
| Torque and Pull out | ||||
| strength tested per | ||||
| ASTM F543. | Torsional, Driving | |||
| Torque and Pull out | ||||
| strength tested per | ||||
| ASTM F543. |
Differences in intended use, material and performance between the proposed and predicate device have been discussed and address. The proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, in respect of safety and effectiveness.
5
Image /page/5/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is smaller than the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2013
Tianiin Walkman Biomaterial Company, Limited % Mid-Link Consulting Company, Limited Ms. Diana Hong General Manager PO Box 120-119 Shanghai, 200120, China
Re: K131759
Trade/Device Name: Metallic Locking Compression Bone Plates and Screws System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS, HWC Dated: July 19, 2013 Received: July 22, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Ms. Diana Hong
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Reportal?roblem/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.
Sincercly yours.
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 2 Indications for Use
Section 2 Indications for Use
K131759 510(k) Number: Device Name: Metallic Locking Compression Bone Plates and Screws System
Indications for Use:
Mctallic Locking Compression Bone Plates and Screws 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)
OR
[]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 I of I
Elizabeth L. Frank -S
Division of Orthopedic Devices