(123 days)
No
The document describes a mechanical orthopedic implant (a cement keel for knee arthroplasty) and its comparison to a predicate device. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on dimensional comparison and leveraging predicate testing for mechanical properties, biocompatibility, sterility, and MRI safety.
Yes
The device is indicated for use in knee arthroplasty for various degenerative joint diseases, correction of functional deformity, and revision procedures, which are all conditions that require medical therapy to restore function or alleviate symptoms.
No
The device description and intended use clearly state that this is a surgical implant (a keel for knee arthroplasty) designed to provide stability and fixation to tibial bases, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant (EVOLUTION® Cement Keel) made from Ti6Al4V alloy, intended for surgical implantation in the knee. It is a hardware device, not software.
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 within the body for surgical procedures (knee arthroplasty). IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details a physical implant made of metal, designed to be surgically placed in the knee. This is consistent with a surgical implant, not an IVD.
- Anatomical Site: The anatomical site is the "Knee," which is a part of the body where a surgical implant would be placed, not where a specimen for IVD testing would be collected.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the EVOLUTION® Cement Keel is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EVOLUTION® Cement Keel 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® Cement Keels are for cemented use only.
Product codes
JWH
Device Description
MicroPort Orthopedics Inc. is seeking clearance to introduce the subject device, the EVOLUTION® Cement Keel, a line extension to the predicate EVOLUTION® Revision Tibial System cleared in K162026. It is a smaller, lower-profile size compared to the existing predicate Modular Keels, is manufactured from Ti6Al4V alloy conforming to ASTM F136, and is compatible with the same tapers as the predicate. The intended use of the subject modular keel is identical to the predicate, which is to provide optional rotational stability and added fixation to the compatible tibial bases.
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
Nonclinical Testing:
A dimensional comparison analysis was performed to compare the subject device to the predicate device. Due to dimensional equivalency between the two devices, predicate axial and rotational distraction testing submitted in K162026 were leveraged to support the subject device. Justifications were leveraged for biocompatibility, sterility and shelf life based on equivalency to the predicate device.
MRI safety evaluation per ASTM F2182-19, FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", issued May 20, 2021, FDA Guidance for "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices" issued March 2016, ASTM F2182-11a, ASTM F2181-11, ASTM F2052-15, ASTM F2213-17, and ASTM F2119-07 (reapproved 2013).
Clinical Testing:
Clinical data was not provided for the subject devices.
Biocompatibility:
Biocompatibility testing was not needed because the subject device does not introduce new or modify existing biocompatibility risk. The subject implant materials are identical to the final sterilized materials of the predicate device for formulation, processing and sterilization. Additionally the overall geometry and site of application are the same.
Key Metrics
Not Found
Predicate Device(s)
EVOLUTION® Revision Tibial System, K162026
Reference Device(s)
N/A
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2023
MicroPort Orthopedics Inc. Jonas Susaraba Regulatory Affairs Specialist II 5677 Airline Rd Arlington, Tennessee 38002
Re: K231947
Trade/Device Name: EVOLUTION® Cement Keel Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 12, 2023 Received: September 14, 2023
Dear Jonas Susaraba:
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 (the 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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.
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 mediation-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 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).
2
Sincerely,
Image /page/2/Picture/3 description: The image contains the name "Lixin Liu-S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. The background is a light blue color, with a faint watermark or design element that is partially visible behind the text.
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
510(k) Number (if known) K231947
Device Name EVOLUTION® Cement Keel
Indications for Use (Describe)
The EVOLUTION® Cement Keel 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® Cement Keels 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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4
Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red four-pointed star. To the right of the icon is the text "MicroPort" in a larger, bold, blue font, with the word "Orthopedics" underneath in a smaller, regular, blue font.
K231947 Page 1 of 4
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® Cement Keel.
| Submitted by: | MicroPort Orthopedics Inc. |
|---|---|
| 5677 Airline Rd, Arlington TN, 38002 | |
| USA | |
| Phone: 866-872-0211 | |
| Fax: 855-446-2247 | |
| Date: | October 30, 2023 |
| Contact Person: | Jonas Susaraba |
| Proprietary Name: | EVOLUTION® Cement Keel |
| Common Name: | Modular Keel |
| 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: | EVOLUTION® Revision Tibial System, K162026 |
5
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 diamond shape. To the right of the square is the text "MicroPort" in a larger, bold, blue font, and below that is the text "Orthopedics" in a smaller, blue font.
N/A Reference Devices:
Device Information
A. Intended Use/Indications for Use Statement
The EVOLUTION® Cement Keel 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® Cement Keels are for cemented use only.
6
Image /page/6/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 four-pointed star. To the right of the square is the text "MicroPort" in a bold, blue font, and below that is the text "Orthopedics" in a smaller, blue font.
B. Device Description
MicroPort Orthopedics Inc. is seeking clearance to introduce the subject device, the EVOLUTION® Cement Keel, a line extension to the predicate EVOLUTION® Revision Tibial System cleared in K162026. It is a smaller, lower-profile size compared to the existing predicate Modular Keels, is manufactured from Ti6Al4V alloy conforming to ASTM F136, and is compatible with the same tapers as the predicate. The intended use of the subject modular keel is identical to the predicate, which is to provide optional rotational stability and added fixation to the compatible tibial bases.
C. Substantial Equivalence Information
The indications for use and the technological characteristics of the subject device are similar but not the same to the predicate device. The design features of the subject device are substantially equivalent to those of the predicate devices and do not create any new worst-case scenarios. The safety and effectiveness of the subject device are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification submission.
D. Nonclinical Testing
A dimensional comparison analysis was performed to compare the subject device to the predicate device. Due to dimensional equivalency between the two devices, predicate axial and rotational distraction testing submitted in K162026 were leveraged to support the subject device. Justifications were leveraged for biocompatibility, sterility and shelf life based on equivalency to the predicate device.
MRI safety evaluation per ASTM F2182-19, FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", issued May 20, 2021, FDA Guidance for "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices" issued March 2016, ASTM F2182-11a, ASTM F2181-11, ASTM F2052-15, ASTM F2213-17, and ASTM F2119-07 (reapproved 2013).
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Biocompatibility
Biocompatibility testing was not needed because the subject device does not introduce new or modify existing biocompatibility risk. The subject implant materials are identical to the final sterilized materials of the predicate device for formulation, processing and sterilization. Additionally the overall geometry and site of application are the same.
7
Image /page/7/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red diamond inside a white circle on the left. To the right of the icon is the text "MicroPort" in a larger, bold, blue font, with "Orthopedics" underneath in a smaller, blue font.
G. Conclusion
Based on the design features, the use of established well-known materials, feature comparisons, indications for use, principle of operations and results of the nonclinical testing, the subject EVOLUTION® Cement Keel has been shown to be substantially equivalent to the legally marketed predicate devices cited in this premarket notification.