(222 days)
The EVOLUTION® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.
The EVOLUTION® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below:
- Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) .
- Available in 8 standard sizes, left and right ●
- . Available in 3 plus sizes, left and right
- Tibial base has holes for augment attachment screws
- System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)
The provided text is a 510(k) Summary for a medical device called the "EVOLUTION® Revision Tibial System." This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how training set ground truth was established) are not applicable or provided in this document as it pertains to a mechanical orthopedic implant, not an AI/software device that would involve such testing.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Evaluation Method) | Reported Device Performance |
|---|---|
| Bacterial Endotoxins (USP endotoxin limit of 20 EU/device) | Found to be less than the USP endotoxin limit of 20 EU/device (non-pyrogenicity established). |
| Fatigue Strength (Cantilever fatigue per ASTM F1800) | Concluded that the subject tibial base will have fatigue properties substantially equivalent to the predicate and is expected to perform as well or better than the predicate device in fatigue loading. |
| Fatigue Strength (3-point fatigue) | Concluded that the subject tibial base will have fatigue properties substantially equivalent to the predicate and is expected to perform as well or better than the predicate device in fatigue loading. |
| Static Evaluation (Axial distraction per ASTM F2009) | Concluded that the subject tibial base will perform as intended. |
| Static Evaluation (Rotational distraction) | Concluded that the subject tibial base will perform as intended. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing described is non-clinical (laboratory/mechanical testing of the implant itself) and does not involve human sample sizes or data provenance in the context of clinical trials or AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for mechanical device performance is established by engineering standards (e.g., ASTM F1800, ASTM F2009) and the physical properties of the materials and design, not by expert human interpretation in a medical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human-interpreted medical data, not for mechanical device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing is based on established engineering standards and specifications (e.g., ASTM standards for fatigue and static evaluation), and the physical test results compared against those standards or the predicate device's established performance.
8. The sample size for the training set
Not applicable. This is a physical orthopedic implant, not a software/AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2017
Microport Orthopedics, Inc. Byron Ledbetter Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K162026
Trade/Device Name: Evolution Revision Tibial Base, Evolution Revision Tibial Block Augment, Evolution Revision Modular Keels, Evolution Revision Stem Adapters (offset And Extension), Evolution Revision Cemented Stem Extensions, Canal Filling Stem Extensions Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer demi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 27, 2017 Received: January 30, 2017
Dear Mr. Ledbetter:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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 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.
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)
Device Name
EVOLUTION® Revision Tibial System
Indications for Use (Describe)
The EVOLUTION® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
Inflammatory degenerative joint disease, including rheumatoid arthritis;
-
Correction of functional deformity
-
Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.
Type of Use (Select one or both, as applicable)
2 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 shows the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red.
510(k) Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® Revision Tibial System.
| Submitted by: | MicroPort Orthopedics Inc. |
|---|---|
| 5677 Airline Rd, Arlington TN, 38002 | |
| Phone: 866-872-0211 | |
| Fax: 855-446-2247 |
| Date: | January 26, 2017 |
|---|---|
| Contact Person: | Byron LedbetterSr. Regulatory Affairs Specialist |
| Proprietary Name: | EVOLUTION® Revision Tibial System |
| Common Name: | Cemented Tibial Base |
| Classification Name and Reference: | 21 CFR 888.3560 - Knee joint patellofemorotibialmetal/polymer/metal semi-constrained cemented prosthesis.Class II |
| Subject Product Code and PanelCode: | Orthopedics/87/JWH |
| Predicate Device: | EVOLUTION® BIOFOAM® Tibial System (K152298) |
| Reference Devices: | ADVANCE® Total Knee System (K061223)ADVANCE® Modular Tibial Component System (K973524)ADVANCE® Revision (K990030)EVOLUTION® MP Total Knee System (K093552) |
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Image /page/4/Picture/0 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a red star-like shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function, Faster" in a smaller font.
DEVICE INFORMATION
A. Intended Use
EVOLUTION® Revision Tibial System
The EVOLUTION® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis:
-
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.
B. Device Description
The EVOLUTION® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below:
- Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) .
- Available in 8 standard sizes, left and right ●
- . Available in 3 plus sizes, left and right
- Tibial base has holes for augment attachment screws
- System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)
C. Substantial Equivalence Information
The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The indications for use are identical to the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate device, as well. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/5/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function. Faster."
D. Nonclinical Testing
The subject EVOLUTION® Revision Tibial System was evaluated for bacterial endotoxins and found to be less than the USP endotoxin limit of 20 EU/device. The testing established the subject product's non-pyrogenicity.
The subject EVOLUTION® Revision Tibial System was evaluated for fatigue strength via two methods: cantilever fatigue per ASTM F1800 and 3-point fatigue.
Additionally, the EVOLUTION® Revision Tibial System received static evaluation via axial distraction per ASTM F2009 and rotational distraction.
The results for fatigue strength concluded that the subject tibial base will have fatigue properties substantially equivalent to the predicate and is expected to perform as well or better than the predicate device in fatigue loading. The results for the static evaluation concluded that the subject tibial base will perform as intended.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Conclusion
The design features, materials information, predicate testing and analysis date provided in this premarket notification adequately support the substantial equivalence of the EVOLUTION® Revision Tibial System.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.