(182 days)
K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing,K160461: Arthrex iBalance BiCompartmental Arthroplasty System,K153586: Arthrex iBalance TKA System,K152382: Arthrex iBalance TKA System,K152252: Arthrex iBalance TKA System,K143047: Arthrex iBalance Patella Implant, Dome,K133854: Arthrex iBalance TKA System,K073120: ACCIN Patellafemoral System,K063782: ACCIN UNI-Knee System,K060670: ACCIN UNI-Knee System
Not Found
No
The summary describes a system of knee implants and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee arthroplasty system intended to treat various disabling joint diseases and deformities, which are therapeutic purposes.
No
Explanation: The provided text describes the Arthrex iBalance Systems as various knee arthroplasty systems comprised of components for use as knee prostheses. Its intended use is for implantation to replace knee joints due to various conditions, not for diagnosing them.
No
The device description explicitly states that the systems are comprised of femoral, tibia, and patellar components for use in knee prosthesis, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a knee arthroplasty system for surgical implantation in patients with various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description states the systems are comprised of femoral, tibia, and patellar components for use in knee prosthesis. These are physical implants used in surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful partial knee replacement or other procedure;
The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.
These components are single use only and are intended for implantation with bone cement.
The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:
- Degenerative arthritis in the distal femur and patella;
- A history of patellar dislocation or fracture;
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
These components are single use only and are intended for implantation with bone cement.
The Arthrex iBalance TKA System is indicated for use in individuals undergoing surgery for:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatic 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;
- Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components: - Ligamentous instability requiring implant bearing surfaces with increased constraint;
- Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).
Arthrex iBalance UKA System is intended for use in unicompartmental knee arthroplasty as a result of.
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
MBH, HSX, KRR
Device Description
The Arthrex Knee Systems encompass the following FDA cleared devices:
- Arthrex iBalance TKA System
- Arthrex iBalance UKA System
- Arthrex iBalance PFJ
- Arthrex iBalance BiCompartmental Arthroplasty System
These systems are comprised of femoral, tibia, and patellar components for use in knee prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) Environment
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
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)
Non-clinical testing and in-vivo electromagnetic simulation per the FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", demonstrated that the Arthrex Knee Systems are "MR Conditional".
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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.
K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing, K160461: Arthrex iBalance BiCompartmental Arthroplasty System, K153586: Arthrex iBalance TKA System, K152382: Arthrex iBalance TKA System, K152252: Arthrex iBalance TKA System, K143047: Arthrex iBalance Patella Implant, Dome, K133854: Arthrex iBalance TKA System, K073120: ACCIN Patellafemoral System, K063782: ACCIN UNI-Knee System, K060670: ACCIN UNI-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.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
November 7, 2017
Arthrex Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K171365
Trade/Device Name: Arthrex Knee Systems Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, HSX, KRR Dated: October 3, 2017 Received: October 11, 2017
Dear Mr. Rogers:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Mr. David Rogers
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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)
Device Name
Arthrex iBalance BiCompartmental Arthoplasty System
Indications for Use (Describe)
When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- · Correction of functional deformities;
- · Revision of previous unsuccessful partial knee replacement or other procedure;
The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.
These components are single use only and are intended for implantation with bone cement.
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 per 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
3
Indications for Use
510(k) Number (if known)
Device Name Arthrex iBalance PFJ
Indications for Use (Describe)
The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:
- · Degenerative arthritis in the distal femur and patella;
- · A history of patellar dislocation or fracture;
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
These components are single use only and are intended for implantation with bone cement.
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 per 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
4
Indications for Use
510(k) Number (if known)
K171365
Device Name Arthrex iBalance TKA System
Indications for Use (Describe)
The Arthrex iBalance TKA System is indicated for use in individuals undergoing surgery for:
· Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatic 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;
- · Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
- · Ligamentous instability requiring implant bearing surfaces with increased constraint;
- · Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CER 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 per 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
5
Indications for Use
510(k) Number (if known) K171365
Device Name Arthrex iBalance UKA System
Indications for Use (Describe)
Arthrex iBalance UKA System is intended for use in unicompartmental knee arthroplasty as a result of.
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- · Correction of functional deformities;
- · Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
| 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 per 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
6
510(k) Summary or 510(k) Statement
| Date Prepared | May 5, 2017 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Project Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex Knee Systems |
| Common Name | Knee Prosthesis |
| Product Code | MBH, HSX, KRR |
| Classification Name | 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated |
| uncemented prosthesis | |
| 21 CFR 888.3560: Prosthesis, Knee, Patellofermorotibial, Semi-Constrained, | |
| Cemented, Polymer/Metal/Polymer | |
| 21 CFR 888.3520: Prosthesis, Knee, Femorotibial, Non-Constrained, | |
| Metal/Polymer | |
| Regulatory Class | II |
| Predicate Device | K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing |
| K160461: Arthrex iBalance BiCompartmental Arthroplasty System | |
| K153586: Arthrex iBalance TKA System | |
| K152382: Arthrex iBalance TKA System | |
| K152252: Arthrex iBalance TKA System | |
| K143047: Arthrex iBalance Patella Implant, Dome | |
| K133854: Arthrex iBalance TKA System | |
| K073120: ACCIN Patellafemoral System | |
| K063782: ACCIN UNI-Knee System | |
| K060670: ACCIN UNI-Knee System | |
| Purpose of | |
| Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| modification to the device labeling for the Arthrex Knee Systems to include the | |
| "MR Conditional" statement in accordance with the FDA Guidance, "Establishing | |
| Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) | |
| Environment". | |
| Device Description | The Arthrex Knee Systems encompass the following FDA cleared devices: |
| ● Arthrex iBalance TKA System | |
| ● Arthrex iBalance UKA System | |
| ● Arthrex iBalance PFJ | |
| ● Arthrex iBalance BiCompartmental Arthroplasty System | |
| These systems are comprised of femoral, tibia, and patellar components for use | |
| in knee prosthesis. | |
| Indications for Use | The Arthrex iBalance TKA System is indicated for use in individuals undergoing |
| surgery for: | |
| ● 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; | |
7
-
Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components: -
Ligamentous instability requiring implant bearing surfaces with ● increased constraint;
-
Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).
Arthrex iBalance UKA System is intended for use in unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful unicompartmental knee replacement ● or other procedure;
- . As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:
- Degenerative arthritis in the distal femur and patella;
- A history of patellar dislocation or fracture;
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
These components are single use only and are intended for implantation with bone cement.
When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:
- Moderately disabling joint disease of the knee resulting from painful ● osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful partial knee replacement or other procedure;
The BiCompartmental Arthroplasty System is not intended to be used as a dualcondyle or tri-compartmental knee.
These components are single use only and are intended for implantation with bone cement.
Performance Data Non-clinical testing and in-vivo electromagnetic simulation per the FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", demonstrated that the Arthrex Knee Systems are "MR Conditional".
8
| | Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Arthrex Knee Systems are substantially equivalent to the predicate device in
which the basic design features and intended uses are the same. Any differences
between the proposed device and the predicate device are considered minor and
do not raise questions concerning safety or effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. |
| | |