(89 days)
K990030 ADVANCE® Revision (CCK System), K142550 EVOLUTION® MP Revision Femur, K063731 ADVANCE® STATURE Femoral Component, K901992 Whiteside Ortholoc Modular Post. Stab. Knee System, K932677 AXIOM Total Knee System, K863668/K871769 Omnifit Series I Total Knee System, K892800/K895639/K911572/K930831 MG II Total Knee System – Flat, AP Lipped, K862837 Omnifit Series I Total Knee System, K882322/K896542/K901457/K914072 Continuum (CKS) Primary Total Knee System, K953439 Ultrack (ADVANCE®) Total Knee, K972626 ADVANCE® Knee System, K990030 ADVANCE® Revision CCK System, K093552 EVOLUTION® MP CS/CR and PS Tibial Inserts, K990030 ADVANCE® Revision CCK Tibial Insert, K162026 EVOLUTION® Revision Tibial Base and Screw, K973524 ADVANCE® Modular Tibial Component, Screw, K063731 ADVANCE® STATURE Femoral Component, K953439 Ultrack (ADVANCE®) Total Knee System, K932677 AXIOM Total Knee System, K972770 ADVANCE® Ultra-Congruent Tibial Insert, K102380 EVOLUTION® MP Total Knee System, K152298 EVOLUTION® BIOFOAM Tibial Base, K063128 ADVANCE® Spiked Porous Tibial Base
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or data processing related to AI/ML.
Yes.
The device replaces a diseased or damaged knee joint to restore function and alleviate pain, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a knee arthroplasty system intended for total knee replacements and revision procedures, not for diagnosing medical conditions.
No
The device description explicitly lists physical components made of cobalt chrome alloy, titanium alloy, and UHMWPE, indicating it is a hardware device, not software-only.
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 device used in vivo (within the body) for surgical procedures (knee arthroplasty). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a system of implants (femoral component, augments, tibial insert, etc.) made of materials like cobalt chrome alloy and titanium alloy, which are typical for surgical implants.
- Anatomical Site: The anatomical site is the knee joint, indicating a device used directly on the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the EVOLUTION® Revision CCK System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EVOLUTION® Revision CCK 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:
- Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
- . Available in 8 standard sizes, left and right
- Available in 2 plus sizes, left and right
- . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap
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
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)
The subject EVOLUTION® Revision CCK system was evaluated for bacterial endotoxins and found to be less than the USP endotoxin limit of 20 EU/device.
The subject EVOLUTION® Revision CCK system was evaluated for patellofemoral contact area, tibiofemoral contact area, tibial post shear fatigue, taper disassembly, and taper fatigue.
Results for patellofemoral contact area testing concluded the subject EVOLUTION® Revision CCK system to perform as well as the predicate K990030 implants in respect to measured contact area. Results for tibiofemoral contact area testing concluded the subject EVOLUTION® Revision CCK System to possess greater maximum contact area than the predicate K990030 implants. Results of tibial post shear fatigue testing concluded the subject EVOLUTION® Revision CCK system to demonstrate greater fatigue resistance than the predicate K990030. Results of taper disassembly testing indicate the subject EVOLUTION® Revision CCK system will withstand typical in vivo disassociation forces as reported in peer reviewed literature. Results of taper fatigue testing demonstrated the subject EVOLUTION® Revision CCK Femoral constructs to achieve taper disassembly values greater than those of the predicate K162026.
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.
K093552 EVOLUTION® MP Total Knee System, K142550 EVOLUTION® MP Revision Femur, K162026 EVOLUTION® Revision Tibial System, K093552 EVOLUTION® MP Total Knee System
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.
K990030 ADVANCE® Revision (CCK System), K142550 EVOLUTION® MP Revision Femur, K063731 ADVANCE® STATURE Femoral Component, K901992 Whiteside Ortholoc Modular Post. Stab. Knee System, K932677 AXIOM Total Knee System, K863668/K871769 Omnifit Series I Total Knee System, K892800/K895639/K911572/K930831 MG II Total Knee System – Flat, AP Lipped, K862837 Omnifit Series I Total Knee System, K882322/K896542/K901457/K914072 Continuum (CKS) Primary Total Knee System, K953439 Ultrack (ADVANCE®) Total Knee, K972626 ADVANCE® Knee System, K990030 ADVANCE® Revision CCK System, K093552 EVOLUTION® MP CS/CR and PS Tibial Inserts, K990030 ADVANCE® Revision CCK Tibial Insert, K162026 EVOLUTION® Revision Tibial Base and Screw, K973524 ADVANCE® Modular Tibial Component, Screw, K063731 ADVANCE® STATURE Femoral Component, K953439 Ultrack (ADVANCE®) Total Knee System, K932677 AXIOM Total Knee System, K972770 ADVANCE® Ultra-Congruent Tibial Insert, K102380 EVOLUTION® MP Total Knee System, K152298 EVOLUTION® BIOFOAM Tibial Base, K063128 ADVANCE® Spiked Porous Tibial Base
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MicroPort Orthopedics Inc. Matt Paul Regulatory Affairs Project Manager 5677 Airline Road Arlington, Tennessee 38002
August 8, 2017
Re: K171389
Trade/Device Name: EVOLUTION Revision CCK System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 10, 2017 Received: May 11, 2017
Dear Matt Paul:
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
1
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
2
Indications for Use
510(k) Number (if known)
K171389
Device Name
EVOLUTION® Revision CCK System
Indications for Use (Describe)
The EVOLUTION® Revision CCK 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 rounded square with a white circle inside, containing a red diamond shape. To the right of the icon, the word "MicroPort" is written in blue, with "Orthopedics" written in red below it. The tagline "Full Function. Faster." is visible below the company name.
EVOLUTION® Revision CCK System 510(k) Summary
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 EVOLUTION® Revision CCK System.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 2, 2017 |
| Contact Person: | Matt Paul |
| Proprietary Name: | EVOLUTION® Revision CCK System |
| Common Name: | Total knee implant |
| Classification Name
and Reference: | 21 CFR 888.3560 - Knee joint patellofemorotibial metal/polymer/metal semi-
constrained cemented prosthesis.
Class II |
| Subject Product Code
and Panel Code: | Orthopedics/87/JWH |
| Predicate Device: | K093552 EVOLUTION® MP Total Knee System
K142550 EVOLUTION® MP Revision Femur
K162026 EVOLUTION® Revision Tibial System
K093552 EVOLUTION® MP Total Knee System |
4
K171389 p.2/5
Image /page/4/Picture/1 description: The image is the logo for MicroPort Orthopedics. The logo features a blue square with a white circle inside, and a red diamond in the center of the circle. 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 blue.
EVOLUTION® Revision CCK System 510(k) Summary
| Reference Devices: | Femoral Component: |
|---|---|
| K990030 ADVANCE® Revision (CCK System) | |
| K142550 EVOLUTION® MP Revision Femur | |
| K063731 ADVANCE® STATURE Femoral Component | |
| K901992 Whiteside Ortholoc Modular Post. Stab. Knee System | |
| K932677 AXIOM Total Knee System | |
| K863668/K871769 Omnifit Series I Total Knee System | |
| K892800/K895639/K911572/K930831 MG II Total Knee System – Flat, AP Lipped | |
| K862837 Omnifit Series I Total Knee System | |
| K882322/K896542/K901457/K914072 Continuum (CKS) Primary Total Knee System | |
| K953439 Ultrack (ADVANCE®) Total Knee | |
| K972626 ADVANCE® Knee System |
Femoral Augment: K990030 ADVANCE® Revision CCK System
Tibial Insert:
K093552 EVOLUTION® MP CS/CR and PS Tibial Inserts K990030 ADVANCE® Revision CCK Tibial Insert K162026 EVOLUTION® Revision Tibial Base and Screw K973524 ADVANCE® Modular Tibial Component, Screw K063731 ADVANCE® STATURE Femoral Component K953439 Ultrack (ADVANCE®) Total Knee System K932677 AXIOM Total Knee System K972770 ADVANCE® Ultra-Congruent Tibial Insert K102380 EVOLUTION® MP Total Knee System K152298 EVOLUTION® BIOFOAM Tibial Base K063128 ADVANCE® Spiked Porous Tibial Base
MicroPort Orthopedics BV Hoogoorddreef 5, 1101 BA Amsterdam, The Netherlands +31 20 545 01 00
5
Image /page/5/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 blue, with "Orthopedics" underneath in red. Below that is the phrase "Full Function. Faster."
Device Information
A. Intended Use
The EVOLUTION® Revision CCK 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
EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:
- Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
- . Available in 8 standard sizes, left and right
- Available in 2 plus sizes, left and right
- . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap
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. 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/6/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 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.
K171389 p.4/5 EVOLUTION® Revision CCK System
510(k) Summary
D. Nonclinical Testing
The subject EVOLUTION® Revision CCK system was evaluated for bacterial endotoxins and found to be less than the USP endotoxin limit of 20 EU/device.
The subject EVOLUTION® Revision CCK system was evaluated for patellofemoral contact area, tibiofemoral contact area, tibial post shear fatigue, taper disassembly, and taper fatigue.
Results for patellofemoral contact area testing concluded the subject EVOLUTION® Revision CCK system to perform as well as the predicate K990030 implants in respect to measured contact area. Results for tibiofemoral contact area testing concluded the subject EVOLUTION® Revision CCK System to possess greater maximum contact area than the predicate K990030 implants. Results of tibial post shear fatigue testing concluded the subject EVOLUTION® Revision CCK system to demonstrate greater fatigue resistance than the predicate K990030. Results of taper disassembly testing indicate the subject EVOLUTION® Revision CCK system will withstand typical in vivo disassociation forces as reported in peer reviewed literature. Results of taper fatigue testing demonstrated the subject EVOLUTION® Revision CCK Femoral constructs to achieve taper disassembly values greater than those of the predicate K162026.
E. Clinical Testing
Clinical data was not provided for the subject devices.
7
K171389 p.5/5
Image /page/7/Picture/1 description: The image is the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle with a red diamond shape in the center. 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."
EVOLUTION® Revision CCK System 510(k) Summary
F. Component and Accessory Compatibility
The subject devices are compatible with the following previously cleared MicroPort Orthopedics products.
Femoral
| K162026 | EVOLUTION® Revision Stem Extensions |
|---|---|
| K162026 | EVOLUTION® Revision Straight Stem Extension Adapters |
| K142550 | EVOLUTION® Revision Distal and Posterior Femoral Augments |
Patella
| K122218 | ADVANCE® Patella |
|---|---|
| K953439 | ADVANCE® Patella |
Tibial
| K162026 | EVOLUTION® Revision Tibial Base |
|---|---|
| K162026 | EVOLUTION® Revision Tibial Augments |
| K162026 | EVOLUTION® Revision Modular Keel |
| K162026 | EVOLUTION® Revision Tibial Stem Offset Adapters |
| K162026 | EVOLUTION® Revision Straight Stem Extension Adapters |
| K162026 | EVOLUTION® Revision Stem Extensions |
The EVOLUTION® Revision CCK System instrumentation includes reamers, trials, guides, broaches, bushings, spacers, drivers, and clamps.
G. Conclusion
The design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of EVOLUTION® Revision CCK.