(57 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are biomechanical tests comparing the strength of the device to a predicate.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used to provide fixation during fractures, fusions, and osteotomies, which is a structural support function rather than an active treatment or prevention of a medical condition. It aids in the healing process by stabilizing, but it doesn't directly treat or cure the underlying condition.
No
Explanation: The device, the Tandry Q-Locking Plate System, is an orthopedic implant intended to provide fixation during fractures, fusions, and osteotomies. It is used for structural support, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of "various sized plates, screws and instruments," which are physical hardware components.
Based on the provided information, the Tandry Q-Locking Plate System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide fixation during fractures, fusions, and osteotomies. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and instruments designed for surgical implantation and bone fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The Tandry Q-Locking Plate System is an implantable medical device used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavic, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
Each plate is indicated for the following anatomic regions:
- 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm Q-locking plates: Radius, wrist, and ulna
- 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia
- 5.0 mm Q-locking plates: Femur and tibia
Product codes
HRS
Device Description
The Tandry Q-Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept, cortex, shaft and cancellous, locking (variable angle) screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. Both plate and screw feature variable angle locking design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, pelvis, scapula, calcaneus, metacarpals, wrist, metatarsals, tarsals, phalanges, radius, ulna, humerus, olecranon, fibula, femur, tibia
Indicated Patient Age Range
Not Found
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
The biomechanical tests were practiced according to ASTM F543-17 for the plate. This test method is intended to compare the strengths of different products. The Tandry Locking Plate system is chosen to compare with Tandry Q-Locking Plate System.
Mechanical performance testing of constructs has been performed to compare the subject Tandry Q-Locking Plate System to the predicate Tandry Locking Plate System. This data supports that the mechanical performance of the subject devices is substantially equivalent to that of the predicate 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2024
Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District, Taichung City, 40763 Taiwan
Re: K242814
Trade/Device Name: Tandry Q-Locking 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 Dated: September 13, 2024 Received: September 18, 2024
Dear Harrison Du:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thomas Mcnamara -S
For: Christopher Ferreira, MS Assistant Director DHT6C: Bone-Soft Tissue Interface and Fracture Fixation Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Tandry Q-Locking Plate System
Indications for Use (Describe)
The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
Each plate is indicated for the following anatomic regions:
- 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm Q-locking plates: Radius, wrist, and ulna
- 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia
- 5.0 mm Q-locking plates: Femur and tibia
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Page 1 of 2
| 510(k) #: K242814 | 510(k) Summary | Prepared on: 2024-11-11 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Microware Precision Co., Ltd. | ||
| Applicant Address | No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763 Taiwan | ||
| Applicant Contact Telephone | 886424636275 | ||
| Applicant Contact | Mr. Harrison Du | ||
| Applicant Contact Email | harrisondu@microware.com.tw | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Tandry Q-Locking Plate System | ||
| Common Name | Single/multiple component metallic bone fixation appliances and | ||
| accessories | |||
| Classification Name | Plate, Fixation, Bone | ||
| Regulation Number | 888.3030 | ||
| Product Code(s) | HRS | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K230690 | Tandry Locking Plate System | HRS | |
| K171904 | Tandry Locking Plate System | HRS | |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTE | HRS | |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
| The Tandry Q-Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for |
local anatomies and can accept, cortex, shaft and cancellous, locking (variable angle) screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. Both plate and screw feature variable angle locking design.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavic, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
Each plate is indicated for the following anatomic regions:
- 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm Q-locking plates: Radius, wrist, and ulna
- 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia
- 5.0 mm Q-locking plates: Femur and tibia
5
Indications for Use Comparison
The indications for use of the Tandry Q-Locking Plate System is the same as the primary predicate device and identical to the relevant sections of the additional predicate indications.
Technological Comparison
The Tandry Q-Locking Plate System shares the same fundamental technological characteristic as the predicate devices (K230690, K171904, and K 141527) including materials, shapes, operation, and package. The only difference is that the screw holes of the Tandry Qlocking plate feature variable angle function.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The biomechanical tests were practiced according to ASTM F543-17 for the plate. This test method is intended to compare the strengths of different products. The Tandry Locking Plate system is chosen to compare with Tandry Q-Locking Plate System.
Mechanical performance testing of constructs has been performed to compare the subject Tandry Q-Locking Plate System to the predicate Tandry Locking Plate System. This data supports that the mechanical performance of the subject devices is substantially equivalent to that of the predicate devices.