(91 days)
No
The summary describes surgical instruments and a technique for total knee replacement, with no mention of AI or ML.
No.
The device described consists of instruments and a technique for performing kinematic alignment in total knee replacement surgery. The therapeutic aspect is the knee replacement itself, which uses the "Evolution® Total Knee Systems" implants. The submitted device is for the instrumentation and technique, not the implantable therapeutic device.
No
The device description indicates that the Evolution® Total Kinematic Alignment Instrumentation and Technique consists of instruments used for surgical alignment and resection in total knee replacement. Its purpose is to facilitate a surgical technique to duplicate the pre-arthritic native joint line during implantation, not to diagnose a condition.
No
The device description explicitly states that the instruments consist of physical components like resection and alignment guides, calipers, spacers, and trays, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device consists of "resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation." These are surgical instruments used during a surgical procedure, not for testing samples outside the body.
- Intended Use: The intended use describes the conditions for which the implants (which the instruments are used to implant) are indicated, and the surgical technique used for implantation. This is related to surgical treatment, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device described is a set of surgical instruments and a surgical technique used for total knee replacement surgery.
N/A
Intended Use / Indications for Use
The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The purpose of this submission is to seek clearance for the Evolution® Total Knematic Alignment Instrumentation and Technique. The instruments consist of resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation. The Kinematic Alignment technique is to duplicate the pre-arthritic native joint line. Unlike Mechanical Alignment where the focus is placed on making a perpendicular tibial resection, non-anatomic distal and posterior femoral cuts, and ligament releases if needed, Kinematic Alignment prioritizes the femoral cuts to replicate the native joint line. The Kinematic Alignment technique compensates for wear on the prearthritic joint line and strives for natural ligament tension.
The Evolution® Kinematic Alignment surgical technique is used with the following 510(k)-cleared knee components. No changes to the compatible Evolution® implants are being presented in this 510(k). The compatible implants are axactly the same as the previously cleared Evolution® implants.
- · Evolution® MP Total Knee System, K093552
- · Evolution® MP Total Knee System, K102380
- · Evolution® MP CS/CR Porous Femur, K140735
- · Evolution® Biofoam® Tibial Base and Evolution Biofoam Modular Keels, K152298
- · Evolution® Revision Tibia Base System, K162026
- · Evolution® Biofoam Tibial Base with Biofoam® Additive Manufacturing, K170288
- · Evolution® Stemmed CS Femur, K182125
- Evolution® NitrX™ Medial-Pivot Knee, K182251
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Kinematic Alignment instrument cadaveric validation of the surgical technique and associated instrumentation.
Not applicable. Clinical data were not necessary for the subject device.
The nonclinical analyses and validations demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices.
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.
K140735, K093552, K102380, K152298, K162026, K170288, K182125, K182251, K173890, K172524
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
§ 888.3560 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
February 18, 2025
MicroPort Orthopedics, Inc. Ryan Ross Senior Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
Re: K243574
Trade/Device Name: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: November 14, 2024 Received: November 19, 2024
Dear Ryan Ross:
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 (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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu-S
Lixin Liu, Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: 0MB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K243574
Device Name
Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
Indications for Use (Describe)
The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity:
The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
| K243574 - Page 1 of 3 | ||||
|---|---|---|---|---|
| 510(k) #: | 510(k) Summary | Prepared on: 2024-11-18 | ||
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | MicroPort Orthopedics Inc. | |||
| Applicant Address | 5677 Airline Road Arlington TN 38002 United States | |||
| Applicant Contact Telephone | 901-867-4401 | |||
| Applicant Contact | Mr. Ryan Ross | |||
| Applicant Contact Email | ryan.ross@ortho.microport.com | |||
| Correspondent Name | MicroPort Orthopedics Inc. | |||
| Correspondent Address | 5677 Airline Road Arlington TN 38002 United States | |||
| Correspondent Contact Telephone | 901-867-4401 | |||
| Correspondent Contact | Mr. Ryan Ross | |||
| Correspondent Contact Email | ryan.ross@ortho.microport.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation | |||
| and Technique | ||||
| Common Name | Total Knee Replacement | |||
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained | |||
| cemented prosthesis | ||||
| Regulation Number | 21 CFR 888.3560, 21 CFR 888.3565 | |||
| Product Code(s) | JWH, MBH | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K1 4073 5 | Evolution® MP CS/CR Porous Femur | MB H | ||
| K093 552 | Evolution® MP Total Knee System | J WH | ||
| K1 023 8 0 | Evolution® MP Total Knee System | J WH | ||
| K152298 | Evolution® Biofoam® Tibia Base and Modular Keels | MBH | ||
| K162026 | Evolution® Revision Tibia Base System | JWH | ||
| K170288 | Evolution® Biofoam® Tibia Base with Biofoam® Additive Manufa | MBH |
5
K243574 - Page 2 of 3
| K182125 | Evolution® Stemmed CS Femur | JWH |
|---|---|---|
| K182251 | Evolution® NitrX™ Medial-Pivot Knee | JWH |
| K173890 | GMK Sphere - Kinematic Alignment | JWH |
| K172524 | Zimmer Persona Personalized Knee System | MBH |
Device Description Summary
21 CFR 807.92(a)(4)## Device Description Summary
The purpose of this submission is to seek clearance for the Evolution® Total Knematic Alignment Instrumentation and Technique. The instruments consist of resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation. The Kinematic Alignment technique is to duplicate the pre-arthritic native joint line. Unlike Mechanical Alignment where the focus is placed on making a perpendicular tibial resection, non-anatomic distal and posterior femoral cuts, and ligament releases if needed, Kinematic Alignment prioritizes the femoral cuts to replicate the native joint line. The Kinematic Alignment technique compensates for wear on the prearthritic joint line and strives for natural ligament tension.
The Evolution® Kinematic Alignment surgical technique is used with the following 510(k)-cleared knee components. No changes to the compatible Evolution® implants are being presented in this 510(k). The compatible implants are axactly the same as the previously cleared Evolution® implants.
- · Evolution® MP Total Knee System, K093552
- · Evolution® MP Total Knee System, K102380
- · Evolution® MP CS/CR Porous Femur, K140735
- · Evolution® Biofoam® Tibial Base and Evolution Biofoam Modular Keels, K152298
- · Evolution® Revision Tibia Base System, K162026
- · Evolution® Biofoam Tibial Base with Biofoam® Additive Manufacturing, K170288
- · Evolution® Stemmed CS Femur, K182125
- Evolution® NitrX™ Medial-Pivot Knee, K182251
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject and predicate devices have intended use. Indications for use remain nearly identical.
6
Technological Comparison
The subject devices possess similar technological characteristics as the predicate and reference devices. Overall design, materials of construction, principles of operation, and funcific technology remain identical. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information and analyses provided within this Premarket Notification.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance testing conducted on the predicate and reference devices are being leveraged in support of this submission:
• Range of Motion
- Tibiofemoral Stability
- · Patellofemoral Stability
Risks were identified based on the proposed surgical technical rationales in comparison to predicate testing:
- · Resection Angle Comparison
- Range of Motion
- Force Analysis
- Tibiofemoral Stability
- · Patellofemoral Stability
- · Wear
The subject Kinematic Alignment instrument cadaveric validation of the surgical technique and associated instrumentation.
Not applicable. Clinical data were not necessary for the subject device.
The nonclinical analyses and validations demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices.