K Number
K153586
Device Name
Arthrex iBalance TKA System
Manufacturer
Date Cleared
2016-02-19

(65 days)

Product Code
Regulation Number
888.3565
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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: - Revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilization 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).
Device Description
The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions, as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Tibial bearing components are offered in PS, CR and CR Plus configurations. The proposed Arthrex iBalance® TKA System line extension of this submission adds Vitamin E blended tibial bearing components and Vitamin E blended patella components to the product offering.
More Information

Not Found

No
The summary describes a total knee arthroplasty system consisting of implants and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.

No.
The device is a knee replacement system intended for surgical implantation to address various knee joint conditions, rather than providing direct therapy.

No

Explanation: The Arthrex iBalance® TKA System is an orthopedic implant for total knee arthroplasty, used to replace damaged knee joints. Its function is to facilitate movement and stability, not to diagnose a condition.

No

The device description explicitly states it consists of physical components like femoral components, tibial tray, tibial bearing components, and patellar components, which are hardware.

Based on the provided information, the Arthrex iBalance® TKA System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The description clearly states that the Arthrex iBalance® TKA System consists of components for implantation in the knee joint during surgery. The intended use is to treat painful and disabling joint disease of the knee.
  • Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is to replace damaged parts of the knee joint.

Therefore, the Arthrex iBalance® TKA System is a surgical implant, not an IVD.

N/A

Intended Use / 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:
    • · Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilization 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).

Product codes (comma separated list FDA assigned to the subject device)

MBH, JWH, OIY

Device Description

The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions, as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Tibial bearing components are offered in PS, CR and CR Plus configurations. The proposed Arthrex iBalance® TKA System line extension of this submission adds Vitamin E blended tibial bearing components and Vitamin E blended patella components to the product offering.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee joint

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 wear, fatigue and shear testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards.

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.

K081127, K133854, K143047, K152252, K152382

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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The seal is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Arthrex, Incorporated Leon Brown, Ph.D. Regulatory Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K153586 Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY Dated: December 27, 2015 Received: December 29, 2015

Dear Dr. Brown:

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

1

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

2

Expiration Date: January 31, 2017

See PRA Statement below

Indications for Use

K153586

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, 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:
    • · Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilization 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)

☑ 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

"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

2.5 510(K) SUMMARY

Date Summary PreparedFebruary 3, 2016
Manufacturer/Distributor/SponsorArthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
510(k) ContactLeon Brown II, Ph.D.
Regulatory Project Manager
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 72028
Fax: 239/598.5508
Email: Leon.Brown@Arthrex.com
Trade NameArthrex iBalance® TKA System
Common NameKnee Prosthesis
Primary Product Code -MBH
Classification Name888.3565: Knee joint patellofemorotibial metal/polymer
CFRporous-coated uncemented prosthesis.
Secondary Product Code -JWH
Classification Name888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-
CFRConstrained, Cemented, Polymer/Metal/Polymer
Tertiary Product Code -OIY
Classification Name888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-
CFRConstrained, Cemented, Polymer/Metal/Polymer
Predicate DeviceK081127: Arthrex iBalance® TKA System
K133854: Arthrex iBalance® TKA System
K143047: Arthrex iBalance® Patella Implant, Dome
K152252: Arthrex iBalance® TKA System
K152382: Arthrex iBalance® TKA System
Purpose of SubmissionThis traditional 510(k) premarket notification is
submitted to obtain clearance for a line extension to the
Arthrex iBalance® TKA System which would add
Vitamin E blended tibial bearing components and Vitamin
E blended patella components to the system.
Device DescriptionThe Arthrex iBalance® TKA System consists of femoral
components, tibial tray, tibial bearing components and
patellar components. All components are available in a
range of sizes to fit varying anatomical requirements.
Femoral components and tibial bearing components are
available in both posteriorly stabilized (PS) and cruciate
retaining (CR) configurations. Femoral components are
available in left and right versions, as well as cemented
and uncemented (biological fixation) versions and are
designed to work with the Arthrex dome patella
components. Tibial bearing components are offered in
PS, CR and CR Plus configurations.
The proposed Arthrex iBalance® TKA System line
extension of this submission adds Vitamin E blended
tibial bearing components and Vitamin E blended patella
components to the product offering.
The Arthrex iBalance® TKA System is indicated for use
Intended 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;
Revisions of previous unsuccessful knee replacement
or other procedure.
for
Additional indications
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).
The proposed Arthrex iBalance® TKA System adds
Vitamin E blended tibial bearing components and Vitamin
E blended patella components to the existing system. The
Arthrex iBalance® TKA System is substantially
equivalent to the predicate device as the dimensions,
general design, intended use, indications for use,
technological characteristics, packaging, storage and
sterilization remain the same. Any differences between
The wear, fatigue and shear testing demonstrates the
Arthrex iBalance® TKA System remains in compliance
with FDA Guidance and industry standards.
Based on the indication for use, technological
characteristics, and the summary of mechanical testing
data submitted, Arthrex, Inc. has determined that the
Arthrex iBalance® TKA System is substantially
equivalent to currently marketed predicate devices.

4

5