(53 days)
Not Found
No
The summary describes a knee arthroplasty system and its components, focusing on mechanical performance and intended use. There is no mention of AI, ML, image processing, or any data related to training or testing of algorithms.
Yes
The device is an arthroplasty system intended to treat disabling joint disease and correct functional deformities in the knee, which are therapeutic interventions.
No
This device is described as an implant system for knee arthroplasty, intended for treatment of joint disease, not for diagnosis.
No
The device description clearly states it is comprised of implant systems (Arthrex iBalance UKA and Arthrex iBalance PFJ), which are physical components intended for implantation.
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 surgical implant system for treating knee joint disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical implants (unicompartmental and patellofemoral systems) designed for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on biomechanical testing and mechanical data related to the implant's function, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace damaged knee joint components.
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 multi-compartmental 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 tricompartmental knee
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)
KRR., HSX
Device Description
The Arthrex iBalance BiCompartmental Arthroplasty System is comprised of a unicompartmental implant system (Arthrex iBalance UKA) and a patellofemoral implant system (Arthrex iBalance PFJ). The Arthrex iBalance UKA and Arthrex iBalance PFJ systems may be used in conjunction to create a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The submitted biomechanical testing data demonstrated the system worked well and the two systems did not impinge on one another. No further instrumentation beyond the existing devices cleared with the original systems was required to perform the procedure. Mechanical data is unchanged from the original clearances; no further mechanical testing is necessary to demonstrate that the iBalance BiCompartmental Arthroplasty System is adequate for its intended use. Clinical data and conclusions are not needed for this device.
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.
K073120, K063782, K060670, K090763, K052917
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
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one in front of the other. The profiles are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2016
Arthrex, Incorporated Courtnev Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K160461 Trade/Device Name: Arthrex iBalance BiCompartmental Arthroplasty System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KRR., HSX Dated: February 12, 2016 Received: February 19, 2016
Dear Courtney Smith:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.1 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Arthrex iBalance BiCompartmental Arthroplasty 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 multi-compartmental 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 tricompartmental 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| Date Summary Prepared | April 6, 2016 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: courtney.smith@arthrex.com | |
| Trade Name | iBalance BiCompartmental Arthroplasty System |
| Common Name | Knee Prosthesis |
| Product Code -Classification Name | |
| CFR | KRR – Knee joint patellofemoral polymer/metal semi- |
| constrained cemented prosthesis, CFR 888.3540 | |
| HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, | |
| Cemented, Metal Polymer CFR 888.3520 | |
| Predicate Device | K073120: ACCIN Patellofemoral System |
| K063782, K060670: ACCIN UNI-Knee System | |
| K090763: Mako Restoris MCK | |
| K052917: Stryker Compartmental Knee System | |
| Purpose of Submission | This traditional 510(k) premarket notification is |
| submitted to obtain FDA clearance for use of the Arthrex | |
| iBalance UKA system in conjunction with the Arthrex | |
| iBalance PFJ System to create the Arthrex iBalance | |
| BiCompartmental Arthroplasty System | |
| Device Description | The Arthrex iBalance BiCompartmental Arthroplasty |
| System is comprised of a unicompartmental implant | |
| system (Arthrex iBalance UKA) and a patellofemoral | |
| implant system (Arthrex iBalance PFJ). The Arthrex | |
| iBalance UKA and Arthrex iBalance PFJ systems may be | |
| used in conjunction to create a bicompartmental | |
| patellofemorotibial replacement for the medial or lateral | |
| side of the knee. | |
| Intended 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 multi-compartmental 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 | |
| Substantial Equivalence Summary | The iBalance BiCompartmental Arthroplasty system is |
| substantially equivalent to the predicate devices in which the basic features and intended uses are the same. Any | |
| differences between the iBalance BiCompartmental Arthroplasty system and the predicates are considered | |
| minor and do not raise questions concerning safety and effectiveness. | |
| The proposed devices are substantially equivalent to the predicate devices in regards to its intended use, design, | |
| size ranges, and materials. | |
| The submitted biomechanical testing data demonstrated the system worked well and the two systems did not | |
| impinge on one another. No further instrumentation beyond the existing devices cleared with the original | |
| systems was required to perform the procedure. Mechanical data is unchanged from the original | |
| clearances; no further mechanical testing is necessary to demonstrate that the iBalance BiCompartmental | |
| Arthroplasty System is adequate for its intended use. Clinical data and conclusions are not needed for this | |
| device. | |
| Based on the indication for use, technological | |
| characteristics, and the comparison to the predicate | |
| devices, Arthrex, Inc. has determined that the iBalance | |
| BiCompartmental Arthroplasty system is substantially | |
| equivalent to currently marketed predicate devices. |
2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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