(122 days)
EVOLUTION® MP Revision Femoral System (K142550)
No
The summary describes a mechanical knee implant and its compatibility with other components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total knee replacement implant used in knee arthroplasty to treat various degenerative conditions and fractures, which falls under the definition of a therapeutic device.
No
Explanation: This device is a knee replacement implant ("EVOLUTION® Stemmed CS Femur") and is used for treatment (arthroplasty) rather than for diagnosing a condition.
No
The device description clearly states it is a physical implant manufactured from Cobalt Chrome Alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for knee arthroplasty to treat various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant (femoral component) made of Cobalt Chrome Alloy, designed to be surgically placed in the knee joint. This is consistent with a medical device for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
MicroPort Total Knee Systems are in knee arthroplasty in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, 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.
Non-porous MicroPort total knee replacement implants are for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The EVOLUTION® Stemmed CS Femur is a line extension of the EVOLUTION® revision knee system product line. The device is a stemmed distal femoral knee joint replacement implant design to address bone-on-bone bearing conditions in a patient's knee where there is also a lack of bone stock or quality, but intact and sufficient collateral ligaments. An optional polyethylene stem cap designed to obstruct bone cement migration into the trunnion is packaged with the subject femoral component in the event no stem extension or adapter is used. The design features are summarized below:
- o Manufactured from Cobalt Chrome Alloy
- o CS design, sizes 1-8, left and right
- Compatible with 510(k) cleared EVOLUTION® Revision Stem Extensions, ● EVOLUTION® Revision Offset Adapters, EVOLUTION® Stem Adapters, EVOLUTION® Revision Femoral Augments, EVOLUTION® MP CS Tibial Inserts, EVOLUTION® Adaptive CS Tibial Inserts, and ADVANCE® Patella Components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 predicate test results were used to support the subject due to equivalencies between devices. Predicate testing included:
-Range of Motion analysis
-Tibiofemoral and patellofemoral Stability/Constraint
-Tibiofemoral and patellofemoral contact area/stress
-Component Interlock Strength
-MR Assessments- Field Interactions, Torque, Displacement, RF Heating
More information on predicate test results supporting subject device can be found in Tab 013 Executive Summary of the 510(k) submission.
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.
EVOLUTION® MP Revision Femoral System (K142550)
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.
EVOLUTION® Revision CCK System (K171389), EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380)
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
§ 888.3560 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.
0
December 6, 2018
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MicroPort Orthopedics Inc. Hunter Williams Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K182125
Trade/Device Name: EVOLUTION Stemmed CS Femur Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 3. 2018 Received: August 6, 2018
Dear Hunter Williams:
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. 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 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 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 medical devices and radiation-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.
Image /page/1/Picture/5 description: The image shows the name "Peter G. Allen -S" on the left side of the image. On the right side of the image, the text "Digitally G. Allen Date: -05'00'" is present. The text on the right side of the image is smaller than the text on the left side of the image. The image appears to be a scan of a document.
Digitally signed by Peter G. Allen -S Date: 2018.12.06 13:43:01
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182125
Device Name EVOLUTION® Stemmed CS Femur
Indications for Use (Describe)
MicroPort Total Knee Systems are in knee arthroplasty in skeletally mature patients with the following conditions:
-
noninflammatory degenerative joint disease including osteoarthritis, 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.
Non-porous MicroPort total knee replacement implants are for cemented use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the text "MicroPort" in a bold, blue font, with "Orthopedics" in a smaller, red font underneath. Below "Orthopedics" is the tagline "Full Function, Faster" in a smaller, light blue font.
K182125 Page 1/4
Image /page/3/Picture/3 description: The image shows the logo for MicroPort Orthopedics. The logo includes a blue square with a red star inside, followed by the text "MicroPort Orthopedics". Below the logo is the text "MicroPort Orthopedics Inc.", followed by the address "5677 Airline Road, Arlington, TN 38002" and the website "ortho.microport.com".
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® Stemmed CS Femur:
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Date: | November 8, 2018 |
| Contact Person: | Hunter E. Williams
Regulatory Affairs Specialist II |
| Proprietary Name: | EVOLUTION® Stemmed CS Femur |
| Common Name: | Stemmed Femoral System |
| Classification Name and Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis
Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/JWH |
| Predicate Device: | EVOLUTION® MP Revision Femoral System (K142550) |
| Reference Devices: | EVOLUTION® Revision CCK System (K171389)
EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380) |
4
Image /page/4/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red star inside, followed by the text "MicroPort" in blue and "Orthopedics" in red. Below the text is the phrase "Full Function, Faster" in a smaller font.
DEVICE INFORMATIO
K182125 Page 2/4
A. Intended Use
MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic 1) arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2)
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
Non-porous MicroPort total knee replacement implants are for cemented use only.
B. Device Description
The EVOLUTION® Stemmed CS Femur is a line extension of the EVOLUTION® revision knee system product line. The device is a stemmed distal femoral knee joint replacement implant design to address bone-on-bone bearing conditions in a patient's knee where there is also a lack of bone stock or quality, but intact and sufficient collateral ligaments. An optional polyethylene stem cap designed to obstruct bone cement migration into the trunnion is packaged with the subject femoral component in the event no stem extension or adapter is used. The design features are summarized below:
- o Manufactured from Cobalt Chrome Alloy
- o CS design, sizes 1-8, left and right
- Compatible with 510(k) cleared EVOLUTION® Revision Stem Extensions, ● EVOLUTION® Revision Offset Adapters, EVOLUTION® Stem Adapters, EVOLUTION® Revision Femoral Augments, EVOLUTION® MP CS Tibial Inserts, EVOLUTION® Adaptive CS Tibial Inserts, and ADVANCE® Patella Components.
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/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Underneath "Orthopedics" is the tagline "Full Function, Faster" in a smaller, blue font.
K182125 Page 3/4
D. Nonclinical Testing
Non clinical predicate test results were used to support the subject due to equivalencies between devices. Predicate testing included:
-Range of Motion analysis
-Tibiofemoral and patellofemoral Stability/Constraint
-Tibiofemoral and patellofemoral contact area/stress
-Component Interlock Strength
-MR Assessments- Field Interactions, Torque, Displacement, RF Heating
More information on predicate test results supporting subject device can be found in Tab 013 Executive Summary of the 510(k) submission.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Biocompatibility
The intended patient contact and materials used in the subject implant devices are identical to those of the predicate devices. No subject implants use colorants. Therefore, biocompatibility testing was not completed on the subject devices.
G. Component and Accessory Compatibility
The subject devices are compatible with the following previously cleared MicroPort Orthopedics products.
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Image /page/6/Picture/1 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 diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath it. Below that is the phrase "Full Function, Faster" in blue.
Page 4/4 K182125
| Component | 510(k) |
|---|---|
| Stem Extensions | |
| EVOLUTION® Revision Canal Filing and Cemented Stem Extensions | K162026 |
| Offset Adapters | |
| EVOLUTION® Revision Femoral Offset Adapters | K171389 |
| Stem Adapters | |
| EVOLUTION® Revision Stem Adapters | K162026 |
| Femoral Augments | |
| EVOLUTION® Revision Femoral Augments | K142550, K171389 |
| Tibial Inserts | |
| EVOLUTION® MP CS Insert | K093552 |
| EVOLUTION® Adaptive CS Inserts | K113325, K140735 |
| Patella Components | |
| ADVANCE® All-Poly Onlay Patella, Tri-Peg | K122218, K953439 |
| ADVANCE® All-Poly Onlay Patella, Single-Peg | K122218, K953439 |
| ADVANCE® All-Poly Recessed Patella, Single-Peg | K953439 |
| ADVANCE® Onlay Metal Back Patella | K122218 |
The EVOLUTION® Stemmed CS Femur instrumentation includes guides, trials, and burrs. The subject devices also utilize instrumentation previously cleared in EVOLUTION® REVISION CCK System (K171389) and EVOLUTION® Revision Tibial System (K162026).
H. Conclusion
The intended use, indications for use, and fundamental scientific technology of the subject devices are identical to the predicate devices. Design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of EVOLUTION® Stemmed CS Femur.