(210 days)
No
The document describes a mechanical knee implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are focused on mechanical properties and wear.
Yes.
Explanation: The device is a knee system indicated for use in knee arthroplasty to correct functional deformities and treat various degenerative joint diseases and fractures, which are therapeutic interventions.
No
Explanation: The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system intended for knee arthroplasty, which is a surgical procedure to replace a damaged knee joint. It is a treatment device, not a diagnostic one, as it does not diagnose a condition but rather functions as a replacement for the knee joint.
No
The device description clearly outlines multiple physical components made of various materials (cobalt chrome alloy, titanium alloy, UHMWPE, PEEK) that are implanted in the body. This is a hardware medical device.
Based on the provided text, the EVOLUTION® Hinge Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various knee conditions in skeletally mature patients. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee prosthesis (femoral component, tibial insert, augments, etc.) made from materials like cobalt chrome alloy and UHMWPE. These are materials used in surgical implants, not for analyzing biological samples.
- Performance Studies: The performance studies focus on mechanical properties, fatigue strength, wear, and MRI safety – all relevant to the performance and safety of a surgical implant within the body. There are no studies related to analyzing biological samples or diagnosing conditions.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
Therefore, the EVOLUTION® Hinge Knee System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic 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.
The EVOLUTION® Hinge Knee System implants are for cemented use only.
Product codes
KRO
Device Description
The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system being introduced as a line extension to MicroPort Orthopedics Inc.'s EVOLUTION® Revision knee portfolio. The system is composed of:
- a femoral component offered in 7 sizes (sizes 2-8) with femoral yoke fixation screw for ● attachment to the yoke assembly
- a hinge yoke assembly offered in 9 sizes based on femur size (size 2-3, 4-6, and 7-8) and tibial insert thickness (small, medium, large)
- a yoke extension stop offered in 3 options (0°, 5°, 10°)
- a tibial insert offered in 8 sizes (sizes 1-8) and in 5 thickness options (12, 14, 17, 20, 24mm)
- a tibial base offered in two variants:
- modular (8 sizes, 1-8) with tibia locking screw for attachment to stem extensions o and stem extension adapters
- monolithic (3 sizes, 1-3) with fixed small keel o
- . Offset adapters (2 sizes, 4mm x 25mm and 8mm x 25mm) and valgus stem adapters (2 sizes, 1° x 25mm and 2° x 25mm)
- Universal femoral augments
- distal augments offered in 7 sizes (sizes B-H) in 4, 8, 12, 16, and 20mm o thicknesses
- posterior femoral augments in 7 sizes (sizes B-H) in 4, 8, and 12mm thicknesses, O
- Medial and lateral tibial augments offered in 8 sizes (sizes 1-8) in 5, 10, and 15mm thicknesses
Components are manufactured from cobalt chrome alloy, titanium alloy, UHMWPE and crosslinked UHMWPE, and PEEK conforming to ASTM F75, F1537 - Alloy 1, F136, F648, F2026, respectively.
The system includes new and existing instrumentation from K140735, K162026, and K171389 to facilitate device implantation.
The subject femoral offset adapters and femoral valgus adapters are not for use with the EVOLUTION® Hinge tibial bases. The subject system is compatible with previously cleared stem extensions, stem extension adapters, and modular keels cleared in K162026 and patellae from K953439 and K122218. Furthermore, the subject universal femoral augments introduced in this 510(k) are backwards compatible with the EVOLUTION® Femurs cleared in K142550, K171389, and K182125.
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)
Nonclinical testing was performed. Clinical data were not provided.
- . Tibial baseplate fatigue strength evaluation (cantilever bend and 3-point bend), including taper disassembly strength and fretting corrosion per ASTM F1800-19, ASTM F2083-21, ISO 14789-1:2000 and ISO 21536:2007
- . Femoral taper fatigue strength, taper disassembly, and fretting corrosion evaluation per ASTM F2009-00
- . Range of motion evaluation per ASTM F2083-12, ISO 21536 (2007), and as recommended per FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA issued on January 16, 2003
- Rotational stop evaluation per ASTM F2083-12 and ASTM F2722-21 .
- . Fatigue strength, torsional stability, post-fatigue disassembly, and fretting corrosion analysis of the subject femoral valgus adapter per ASTM F2009-00 (2011)
- Femorotibial and patellofemoral contact area evaluation per FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA issued on January 16, 2003
- Wear and wear fatigue testing per ISO 14243-1 (2009), and particle analysis per ASTM F1877-16, ASTM F561-13, and ISO 17853-2011
- Anterior/Posterior shear fatigue evaluation of the subject construct
- Torque evaluation and compression testing of the subject femoral fixation screw per FDA Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Component Draft issued May 1995. Results were compared to non-predicate benchmarks.
- . MRI safety evaluation per ASTM F2182-19 and 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). Results were compared to non-predicate benchmarks.
Previous analyses were leveraged on the basis of feature equivalence to the reference devices:
- UHMWPE material property characterization
- . Patellofemoral stability
- Femoral condylar fatigue
The subject device was evaluated for biological safety as guided by the applicable sections of ISO 10993-1:2018 and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 4, 2020). All necessary biological endpoint testing was completed as needed per the standard. Based on the chemical characterization, endpoint testing, predicate performance, and overall biological risk assessment per ISO 10993-1:2018, the subject EVOLUTION® Hinge Knee System is concluded biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GUARDIAN® Limb Salvage System, K013035
Reference Device(s)
EVOLUTION® Revision CCK Knee System, K171389, EVOLUTION® Revision Tibia Base System, K162026, EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments, K142550, EVOLUTION® Stemmed CS Femur, K182125, EVOLUTION® MP Total Knee System, K093552, ADVANCE® Total Knee System - Patella, K122218, ULTRACK Total Knee System, K953439, ADVANCE® Revision CCK Knee System, K990030, ADVANCE® A-CLASS® Insert, K081479, REPIPHYSIS® Limb Salvage System, K021489, ADVANCE® Modular Tibial Component, K973524
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. 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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2023
MicroPort Orthopedics Inc. Ryan Ross Senior Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
Re: K230563
Trade/Device Name: EVOLUTION® Hinge Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO Dated: August 25, 2023 Received: August 29, 2023
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 (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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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 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,
Image /page/1/Picture/5 description: The image contains the name "Lixin Liu -S" in a large, bold font. The text is black and is set against a light background. The text appears to be the main subject of the image.
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
2
Indications for Use
Submission Number (if known)
Device Name
EVOLUTION® Hinge Knee System
Indications for Use (Describe)
The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with 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:
-
revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Hinge Knee System implants are for cemented use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours be response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red star inside, followed by the text "MicroPort" in a larger, bold blue font. Below "MicroPort" is the word "Orthopedics" in a smaller, regular blue font.
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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of EVOLUTION® Hinge Knee System.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
USA
Phone: 866-872-0211
Fax: 855-446-2247 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date: | September 27, 2023 |
| Contact Person: | Ryan Ross |
| Proprietary Name: | EVOLUTION® Hinge Knee System |
| Common Name: | Hinge Knee System |
| Classification Name and
Reference: | 21 CFR 888.3510 – Knee joint femorotibial metal/polymer constrained
cemented prosthesis
Class II |
| Review Panel and Subject
Product Code: | Orthopedics/KRO |
| Predicate Device: | GUARDIAN® Limb Salvage System, K013035 |
4
Image /page/4/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 diamond shape. To the right of the square is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a smaller, blue font.
Reference Devices: EVOLUTION® Revision CCK Knee System, K171389 EVOLUTION® Revision Tibia Base System, K162026 EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments, K142550 EVOLUTION® Stemmed CS Femur, K182125 EVOLUTION® MP Total Knee System, K093552 ADVANCE® Total Knee System - Patella, K122218 ULTRACK Total Knee System, K953439 ADVANCE® Revision CCK Knee System, K990030 ADVANCE® A-CLASS® Insert, K081479 REPIPHYSIS® Limb Salvage System, K021489 ADVANCE® Modular Tibial Component, K973524
Device Information
A. Intended Use Statement
The EVOLUTION® Hinge Knee System is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients. Indications for use are as follows:
Indications for Use
The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic 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.
The EVOLUTION® Hinge Knee System implants are for cemented use only.
5
Image /page/5/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 square is the text "MicroPort" in a bold, blue sans-serif font, with the word "Orthopedics" in a smaller font size directly below it.
B. Device Description
The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system being introduced as a line extension to MicroPort Orthopedics Inc.'s EVOLUTION® Revision knee portfolio. The system is composed of:
- a femoral component offered in 7 sizes (sizes 2-8) with femoral yoke fixation screw for ● attachment to the yoke assembly
- a hinge yoke assembly offered in 9 sizes based on femur size (size 2-3, 4-6, and 7-8) and tibial insert thickness (small, medium, large)
- a yoke extension stop offered in 3 options (0°, 5°, 10°)
- a tibial insert offered in 8 sizes (sizes 1-8) and in 5 thickness options (12, 14, 17, 20, 24mm)
- a tibial base offered in two variants:
- modular (8 sizes, 1-8) with tibia locking screw for attachment to stem extensions o and stem extension adapters
- monolithic (3 sizes, 1-3) with fixed small keel o
- . Offset adapters (2 sizes, 4mm x 25mm and 8mm x 25mm) and valgus stem adapters (2 sizes, 1° x 25mm and 2° x 25mm)
- Universal femoral augments
- distal augments offered in 7 sizes (sizes B-H) in 4, 8, 12, 16, and 20mm o thicknesses
- posterior femoral augments in 7 sizes (sizes B-H) in 4, 8, and 12mm thicknesses, O
- Medial and lateral tibial augments offered in 8 sizes (sizes 1-8) in 5, 10, and 15mm thicknesses
Components are manufactured from cobalt chrome alloy, titanium alloy, UHMWPE and crosslinked UHMWPE, and PEEK conforming to ASTM F75, F1537 - Alloy 1, F136, F648, F2026, respectively.
The system includes new and existing instrumentation from K140735, K162026, and K171389 to facilitate device implantation.
The subject femoral offset adapters and femoral valgus adapters are not for use with the EVOLUTION® Hinge tibial bases. The subject system is compatible with previously cleared stem extensions, stem extension adapters, and modular keels cleared in K162026 and patellae from K953439 and K122218. Furthermore, the subject universal femoral augments introduced in this 510(k) are backwards compatible with the EVOLUTION® Femurs cleared in K142550, K171389, and K182125.
6
Image /page/6/Picture/0 description: The image is a logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners on the left side, containing a white circle with a red diamond inside. To the right of the square is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" in a smaller, blue font underneath.
C. Substantial Equivalence Discussion
The design features and materials of the subject device are substantially equivalent to those of the predicate device and reference devices. The indications for use and intended patient populations are identical to the predicate device. The fundamental scientific technology of the subject device has not changed relative to the predicate device. 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.
D. Nonclinical Testing
Nonclinical testing results were used to support the performance and safety and effectiveness of the subject device and were compared to predicate device and reference device results.
- . Tibial baseplate fatigue strength evaluation (cantilever bend and 3-point bend), including taper disassembly strength and fretting corrosion per ASTM F1800-19, ASTM F2083-21, ISO 14789-1:2000 and ISO 21536:2007
- . Femoral taper fatigue strength, taper disassembly, and fretting corrosion evaluation per ASTM F2009-00
- . Range of motion evaluation per ASTM F2083-12, ISO 21536 (2007), and as recommended per FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA issued on January 16, 2003
- Rotational stop evaluation per ASTM F2083-12 and ASTM F2722-21 .
- . Fatigue strength, torsional stability, post-fatigue disassembly, and fretting corrosion analysis of the subject femoral valgus adapter per ASTM F2009-00 (2011)
- Femorotibial and patellofemoral contact area evaluation per FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA issued on January 16, 2003
- Wear and wear fatigue testing per ISO 14243-1 (2009), and particle analysis per ASTM F1877-16, ASTM F561-13, and ISO 17853-2011
- Anterior/Posterior shear fatigue evaluation of the subject construct
- Torque evaluation and compression testing of the subject femoral fixation screw per FDA Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Component Draft issued May 1995. Results were compared to non-predicate benchmarks.
- . MRI safety evaluation per ASTM F2182-19 and 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). Results were compared to non-predicate benchmarks.
7
Image /page/7/Picture/0 description: The image shows 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 word "MicroPort" in blue, with the word "Orthopedics" in a smaller font size below it, also in blue. The logo is clean and modern, with a focus on the company name.
Previous analyses were leveraged on the basis of feature equivalence to the reference devices:
- UHMWPE material property characterization
- . Patellofemoral stability
- Femoral condylar fatigue
E. Clinical Testing
Clinical data were not provided for the subject device.
F. Biocompatibility
The subject device was evaluated for biological safety as guided by the applicable sections of ISO 10993-1:2018 and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 4, 2020). All necessary biological endpoint testing was completed as needed per the standard. Based on the chemical characterization, endpoint testing, predicate performance, and overall biological risk assessment per ISO 10993-1:2018, the subject EVOLUTION® Hinge Knee System is concluded biocompatible.
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® Hinge Knee System has been shown to be substantially equivalent to the legally marketed predicate device cited in this premarket notification.