(88 days)
Not Found
No
The 510(k) summary describes a mechanical plating and screw system for bone fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical testing.
No.
The device is a plating system and screws intended for the fixation of bone fractures, osteotomies, and non-unions, which are structural repair functions, not therapeutic in nature.
No
Explanation: The device is a plating system intended for fixation of fractures, osteotomies, and non-unions, and for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of stainless steel (plates and screws), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna" and for use in "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones." These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a "Plating System" consisting of plates and screws made from stainless steel. These are physical implants used to stabilize bone.
- 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Wright's EVOLVE® TRIAD™ Plating System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna.
The ORTHOLOC™ Mini polyaxial locking screws are intended for use with Wright's plates manufactured from implant grade stainless steel that accept ORTHOLOCT™ Mini polyaxial locking screws.
The EVOLVE® TRIAD™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device, including the clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges).
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The EVOLVE® TRIAD™ Plating System consists of 9 plates, each belonging to 1 of 3 general categories-radial head, radial neck, and coronoid-based on the contouring of each plate. The radial head and radial neck plates feature poly-axial locking screw holes, the coronoid plates feature non-locking screw holes only.
All EVOLVE® TRIAD™ plates are made from Stainless Steel. The radial head and radial neck plates accept the 2.0mm ORTHOLOC™ Mini polyaxial locking screws and the 2.0mm EVOLVE® TRIAD™ non-locking bone screws. The coronoid plates accept the 2.0mm EVOLVE® TRIAD™ non-locking bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon, radius, ulna, clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges)
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)
Substantial equivalence is shown through worst-case plate analysis screw and construct torque to failure, polyaxial performance, and pull out testing. The results of the test show that the subject EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws can be expected to perform at least as well as the legally marketed predicate EVOLVE® EPS ORTHOLOC™ System and the Syntec-Taichung Non-Sterile Bone Screw Implants.
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.
K102352-EVOLVE® EPS ORTHOLOCTM System, K983495- Syntec-Taichung Non-Sterile Bone Screw Implants
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
KII | 432 (pa 1/3)
AUG 1 9 2011
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drig Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws.
Wright Medical Technology, Inc. A.1. Submitted By: 5677 Airline Rd Arlington, TN 38002 May 20, 2011 Date: Angela Smith Contact Person: Regulatory Affairs Specialist (901) 867-4184 EVOLVE® TRIAD™ Plating System and A.2. Proprietary Name EVOLVE® TRIAD™ Bone Screws Plate System and Bone Screws Common Name: 21 CFR 888,3030-Class II Device Classification Regulation: 21 CFR 888.3040-Class II HRS: Plate, Fixation Bone Device Product Code & Panel: HWC: Screw, Fixation Bone 87 Orthopedics K102352-EVOLVE® EPS ORTHOLOCTM A.3. Predicate Device: System K983495- Syntec-Taichung Non-Sterile Bone Screw Implants
A.3. Device Description
The EVOLVE® TRIAD™ Plating System consists of 9 plates, each belonging to 1 of 3 general categories-radial head, radial neck, and coronoid-based on the contouring of each plate. The radial head and radial neck plates feature poly-axial locking screw holes, the coronoid plates feature non-locking screw holes only.
All EVOLVE® TRIAD™ plates are made from Stainless Steel. The radial head and radial neck plates accept the 2.0mm ORTHOLOC™ Mini polyaxial locking screws and the 2.0mm EVOLVE® TRIAD™ non-locking bone screws. The coronoid plates accept the 2.0mm EVOLVE® TRIAD™ non-locking bone screws.
1
The design features of the EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws are substantially equivalent to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System and the Syntec-Taichung Non-Sterile Bone Screw Implants.
A.4. Intended Use
Wright's EVOLVE® TRIAD™ Plating System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna.
The ORTHOLOC™ Mini polyaxial locking screws are intended for use with Wright's plates manufactured from implant grade stainless steel that accept ORTHOLOCT™ Mini polyaxial locking screws.
The EVOLVE® TRIAD™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of boncs appropriate for the size of the device, including the clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges).
A.5. Technological Characteristics Comparison
The EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws and the legally marketed predicate devices EVOLVE® EPS ORTHOLOC™ System and the Syntec Bone Screw Implants have similar indications, utilize similar instrumentation, are manufactured from Stainless Steel, and are included in the size range of the legally marketed predicate.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence is shown through worst-case plate analysis screw and construct torque to failure, polyaxial performance, and pull out testing. The results of the test show that the subject EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws can be expected to perform at least as well as the legally marketed predicate EVOLVE® EPS ORTHOLOC™ System and the Syntec-Taichung Non-Sterile Bone Screw Implants.
The safety and effectiveness of the subject EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
2
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through worst-case plate analysis and torque to failure, polyaxial performance, and pull out/pull through testing. The subject plates are similar to the predicate plates in material, anatomical design and selection, materials, and similar in indications, and instrumentation utilized. The subject screws are similar in indication for use, size range and material to the predicate, and differ in diameter, driver type. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Ms. Angela Smith Regulatory Affairs Specialist 5677 Airline Road Arlington. Tennessee 38002
AUG 1 9 2011
Re: K111432
Trade/Device Name: EVOLVE® Triad™ Plating System and EVOLVE® Triad™ Bone 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: May 20, 2011 Received: May 23, 2011
Dear Ms. Smith:
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.
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Page - 2 - Ms. Angela Smith
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 nust 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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark H. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: _EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws
Indications For Use:
Wright's EVOLVE® TRIAD™ Plating System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna.
The ORTHOLOC™ Mini polyaxial locking screws are intended for use with Wright's plates manufactured from implant grade stainless steel that accept ORTHOLOC™ Mini polyaxial locking screws.
The EVOLVE® TRIAD™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device, including the clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for m.melkerm
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111432