(449 days)
Not Found
No
The summary describes a mechanical orthopedic implant system (plates, screws, and instruments) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are biomechanical tests, not related to AI/ML performance.
No.
The device is a medical implant (locking plate system) used to provide fixation for bones during fractures, fusions, and osteotomies; it does not actively deliver therapy.
No
The device, the Tandry Locking Plate System, is intended for fixation during fractures, fusions, and osteotomies. It is a surgical implant system, not a device used to diagnose medical conditions or diseases.
No
The device description explicitly states that the system consists of "various sized plates, screws and instruments," which are physical hardware components used in surgical procedures.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Tandry Locking Plate System is a surgical implant used to fix fractures, fusions, and osteotomies in bones. It is physically implanted into the body to provide structural support.
The description clearly indicates that this device is used in vivo (within the living body) for mechanical support and fixation, not for analyzing biological samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.
Each plate is indicated to be used in the following anatomic regions:
- · 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- · 2.4mm locking plates Radius, wrist, and ulna
- · 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- · 5.0 mm locking plates Femur and tibia
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, pelvis, scapula, calcaneal, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
proximal femur (trochanteric, intertrochanteric, and basilar neck fracture).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test: Biomechanical Test.
The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry Locking Plate System including the performance of plate and screw. Results indicate that the subject plate and screw are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
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.
K072562, K062564, K023802, K011978, K013248, K063049, K090047
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.
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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 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.
Microware Precision Co., Ltd. Harrison Du General Manager No. 12. Keyuan 2nd Rd., Situn District Taichung City 407630 Taiwan
Re: K171904
Trade/Device Name: Tandry 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, HWC Dated: June 19, 2017 Received: June 26, 2017
September 18, 2018
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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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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Indications for Use
510(k) Number (if known) K171904
Device Name Tandry Locking Plate System
Indications for Use (Describe)
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.
Each plate is indicated to be used in the following anatomic regions:
- · 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- · 2.4mm locking plates Radius, wrist, and ulna
- · 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- · 5.0 mm locking plates Femur and tibia
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 C.FR 801 Subnart D) | Over-The-Counter Ise (21 CFR 801 Subpart C) |
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3
Microware
510(K) Summary
Submitter's Name: Microware Precision Co., Ltd. Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Tel: +886-4-24636275 # 100 Fax: +886-4-24636276
Contact Name: Harrison Du
Preparation date: Sep, 18, 2018
Registration Number: 3007738812
Device Name: Tandry Locking Plate System
Common Name: Bone Plate and Bone Screw
Classification Name: Class II, 21 CFR 888.3030 and 21 CFR 888.3040
Product Code: HWC and HRS
Predicate Device Information:
Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System (K072562) Synthes LCP Distal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP System (K063049) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047)
Device Description:
The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
Indication for use:
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Microware
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, Tandry Locking Hip Plate System is intended for use in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture.
Each plate is indicated to be used in the following anatomic regions:
- 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm locking plates Radius, wrist, and ulna
- 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- · 5.0 mm locking plates Femur and tibia
Technological Characteristics:
The Tandry Locking Plate System is fabricated from stainless steel 316L per ASTM F139, titanium alloy per ASTM F136 and unalloyed titanium per ASTM F67. The design feature for the Tandry Locking Plate System are similar to the predicate devices including dimensions, shape and sizes.
Summary of Performance Data (Nonclinical and/or Clinical)
Clinical Test
Clinical studies are not required to support substantially equivalent.
Non-Clinical Test
-
Biomechanical Test
The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry Locking Plate System including the performance of plate and screw. Results indicate that the subject plate and screw are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness. -
The Tandry Locking Plate System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Tandry Locking Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
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Microware
Summary of Substantial Equivalence:
The Tandry Locking Plate System is substantially equivalent to the predicated devices. Result of non-clinical tests and the similarities with the legally marketed predicate device indicate the device will perform within the intended use and no new issues of safety or efficacy have been raised.