(297 days)
The TRAX® CR Total Knee System is indicated for use:
- In primary total knee arthroplasty (TKA) as a result of:
- · Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- · Post-traumatic loss of knee joint configuration and function.
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- In revision of previous osteotomy,
- In revision of previous unsuccessful unicompartimental or femoro-patellar knee.
The TRAX® CR Total Knee System is for single use only and is intended for implantation with bone cement only.
The TRAX® CR Total Knee System belongs to the category of Cruciate Retaining (CR) total knee prostheses (only anterior-cruciate is sacrificed).
The TRAX® CR Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral component, a tibial implant and a patellar component. The tibial implant consists of two components: bearing insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.
The provided document is a 510(k) premarket notification for the TRAX® CR Total Knee System. This type of notification focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data and performance metrics against specific acceptance criteria like those often seen for AI/ML devices or novel technologies.
Therefore, many of the requested details about acceptance criteria, device performance tables, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information are not applicable to this specific document or the type of regulatory submission it represents.
However, I can extract the information that is present and indicate where the requested information is not provided.
TRAX® CR Total Knee System: Substantial Equivalence Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM F1814-15 (Disassembly forces) | Testing conducted according to FDA guidance documents. |
| ASTM F1223-20 (Tibio-femoral constraint) | Testing conducted according to FDA guidance documents. |
| ASTM F2083-20 (Tibio-femoral contact stresses) | Testing conducted according to FDA guidance documents. |
| ISO 14243-1 (2009) (Tibio-femoral wear) | Testing conducted according to FDA guidance documents. |
| ASTM F1800-19 (Baseplate fatigue) | Testing conducted according to FDA guidance documents. |
| ASTM F1223-20 (Patello-Femoral Constraint) | Testing conducted according to FDA guidance documents. |
| ASTM F2083-21 (Patello-Femoral contact area stress) | Testing conducted according to FDA guidance documents. |
| ASTM F1800-19 (Stem interlock strength) | Testing conducted according to FDA guidance documents. |
| ASTM F2759-19 (Characterization of AXPE polyethylene) | Testing conducted according to FDA guidance documents. |
| ASTM F2052-2021 (MRI compatibility testing) | Testing conducted according to FDA guidance documents. |
| ISO 10993 (Biocompatibility testing) | Testing conducted according to FDA guidance documents. |
| [Implicit: Substantial Equivalence] | "Amplitude considers the TRAX CR Total Knee System to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." |
Explanation: The "acceptance criteria" here are the recognized FDA/international standards for mechanical and material testing of total knee systems. The "reported device performance" is a general statement indicating that testing was conducted per FDA guidance and that the device meets the criteria for substantial equivalence, implying it performed acceptably against these standards when compared to the predicate devices. Specific quantitative results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document refers to non-clinical bench testing, not clinical studies with patients. The sample sizes for the various mechanical and material tests (e.g., number of components tested for fatigue, wear, etc.) are implicitly defined by the referenced ASTM and ISO standards but are not explicitly reported in this summary.
- Data Provenance: Not applicable. The data comes from bench testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is a non-clinical submission. Ground truth for bench testing is established by the design of the test method and instrumentation to measure physical properties according to established standards.
4. Adjudication Method for the Test Set
- Not applicable. This is a non-clinical submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. This type of study is typically for evaluating diagnostic or interpretive devices with human readers, which is not the case for a knee implant. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. Standalone (Algorithm Only) Performance Study
- Not applicable/No. This is a physical medical device (knee implant), not an algorithm or software-only device.
7. Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" is based on engineering specifications and measurements conforming to the referenced ASTM and ISO standards. This includes properties like material strength, wear resistance, disassembly forces, and constraint.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device. The "training" in this context refers to the design and manufacturing process, which is established through engineering and quality control procedures, not through a 'training set' of data like in machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is a physical device. The device's design and manufacturing rely on established engineering principles, material science, and quality management systems (like 21 CFR Part 820), rather than a ground truth established for a data training set.
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November 3, 2023
Amplitude % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K230078
Trade/Device Name: TRAX® CR Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 30, 2023 Received: October 30, 2023
Dear J.D. Webb:
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.
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ing and identifying as provided in the FDA
Page 2
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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu -S" in a simple, sans-serif font. The text is black and appears to be centered on a white background. The letters are clear and legible, with a consistent font size and spacing.
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
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Indications for Use
Submission Number (if known)
Device Name
TRAX® CR Total Knee System
Indications for Use (Describe)
The TRAX® CR Total Knee System is indicated for use:
-
In primary total knee arthroplasty (TKA) as a result of:
-
· Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
-
· Post-traumatic loss of knee joint configuration and function.
-
Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
-
In revision of previous osteotomy,
-
In revision of previous unsuccessful unicompartimental or femoro-patellar knee.
The TRAX® CR Total Knee System is for single use only and is intended for implantation with bone cement 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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510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Amplitude is hereby submitting this 510(k) Summary.
Date Prepared
October 31, 2023
Submitter [510(k) owner]
Amplitude 11, Cours Jacques Offenbach, ZA Mozart 2 26000 Valence, France Phone: + 33(0)475418741
Primary Contact
J.D. Webb 4313 W. 3800 S West Haven, UT 84401 Phone: 512-590-5810 e-mail: jdwebb@orthomedix.net
Submitted Device Information
Trade Name: TRAX® CR Total Knee System Common Name: Total knee
Classification Information
Classification: Class II Regulation Number: 21 CFR 880.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis
Product Code: JWH Device Panel: Orthopedic
Legally Marketed Predicate Devices
The TRAX® CR Total Knee System manufactured by Amplitude is substantially equivalent to the following device currently in commercial
Primary Predicate Device
| Device: | Persona Knee System |
|---|---|
| Company: | Zimmer-Biomet |
| 510(k) number: | K113369/K193223 |
Secondary Predicate Device
Device: Anatomic Total Knee System Company: Amplitude 510(k) number: K161414
Submitted Device Description
The TRAX® CR Total Knee System belongs to the category of Cruciate Retaining (CR) total knee prostheses (only anterior-cruciate is sacrificed).
The TRAX® CR Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral component, a tibial implant and a patellar component. The tibial implant consists of two components: bearing insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
The selection of the appropriate implants can be made by using the recommendations of the surgical
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technique and by using the x-ray templates and trial implants supplied with the instrumentation.
Materials
K230078 TRAX CR Total Knee System
CoCrMo alloy (ISO 5832-4)
Antioxidant (vitamin E) doped highly crossed linked polyethylene (AO-XLPE or A.X.P.E) (ASTM F648-14, ASTM F2565-13 and ASTM F2695-12)
Stainless-steel alloy according to ISO 5832-9 (M30NW)
Indications for Use
The TRAX® CR Total Knee System is indicated for use:
In primary total knee arthroplasty (TKA) as a result of:
- . Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- . Post-traumatic loss of knee joint configuration and function.
- . Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
In revision of previous osteotomy,
In revision of previous unsuccessful unicompartimental or femoro-patellar knee.
The TRAX® CR Total Knee System is for single use only and is intended for implantation with bone cement only.
Substantial Equivalence
The TRAX® CR Total Knee System is substantially equivalent to the predicate device in terms of intended use, design, manufacturing materials, principles of operation, and technical characteristics and raises no different issues of safety or effectiveness.
Summary of the Technological Characteristics Compared to Predicate
Intended Use
The TRAX CR and Persona are cruciate retaining knees to be used in total knee arthroplasty, revision of previous osteotomy, or revision of previous unsuccessful unicompartmental or femoro-patellar knee.
Materials
All femoral components are fabricated from CoCrMo per ISO 5832-4. The TRAX CR and ANATOMIC tibial baseplates are manufactured using CoCrMo per ISO 5832-4. Tibial inserts and patella components of the TRAX CR are manufactured from Vitamin E doped highly crossed linked polyethylene. Standard keels and extension keels are manufactured from CoCrMo per ISO 5832-4.
Design
The TRAX CR and Persona are cruciate retaining knees with anatomic (right/left) femoral components and tibial baseplates. All femoral components have a single radius of curvature. All baseplates have delta shaped keels. All devices have patellas that are spherical dome shaped.
Dimensions
The TRAX CR implants have similar dimensions as the predicates.
Anchorage to bone:
All systems are for implantation with bone cement.
Non-clinical Test Summary
Bench testing outlined below was conducted according to FDA guidance documents:
- Disassembly forces for tibial baseplate and insert per ASTM F1814-15
- Tibio-femoral constraint per ASTM F1223-20 ●
- Tibio-femoral contact stresses per ASTM F2083-2 ●
- Tibio-femoral wear per ISO 14243-1 (2009) ●
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- Baseplate fatigue per ASTM F1800-19 ●
- Patello-Femoral Constraint per ASTM F1223-20 .
- Patello-Femoral Constraint per ASTM F1223-20
Patello-Femoral contact area stress per ASTM F2083-21 K230078 TRAX CR Total Knee System
Chamintaly de translike are ARTM E4000 10 ● - Stem interlock strength per ASTM F1800-19
- Characterization of AXPE polyethylene per ASTM F2759-19 .
- MRI compatibility testing per ASTM F2052-2021 .
- Biocompatiblity testing per ISO 10993 .
Clinical Test Summary
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Conclusions:
Amplitude considers the TRAX CR Total Knee System to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
§ 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.