(84 days)
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is an implantable knee prosthetic designed to treat various knee joint conditions, including osteoarthritis and rheumatoid arthritis, by restoring joint function, which aligns with the definition of a therapeutic device.
No
The device is a knee implant intended for total knee arthroplasty procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a femoral component and tibial inserts made of physical materials (Co-Cr-Mo and UHMWPE) intended for surgical implantation. This is a hardware device, not software.
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 for total knee arthroplasty. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee implant (femoral component and tibial inserts) made from materials like Co-Cr-Mo and UHMWPE. These are materials used in surgical implants, not for in vitro diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue), reagents, or any process related to diagnosing a disease or condition outside of the body.
- Performance Studies: The performance studies listed are related to the mechanical and functional performance of the implant (range of motion, constraint, wear), which are relevant for a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used to replace a damaged knee joint, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications:
- Loss of knee joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
The Balanced Knee® System TriMax™ CR femoral component is a highly polished Co-Cr-Mo cruciate retaining femoral component that is designed to accommodate increased range of motion up to 150° of flexion. E-Vitalize® CR and UC tibial inserts are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE (same material as K131337). All components are single use only and the TriMax™ CR femoral component is intended for cemented use only.
The E-Vitalize® CR and UC tibial inserts may be used with TriMax™ CR or BKS CR femoral components. E-Vitalize® CR and UC tibial inserts may also be used with all Ortho Development's tibial tray component offerings. The TriMax™ CR femoral component may be used with all Ortho Development patella component offerings.
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 following non-clinical evaluations were performed and demonstrated substantial equivalence to the predicate devices: Range of Motion, Femorotibial Constraint, Femorotibial Contact Area, Patellofemoral Constraint, Patellofemoral Contact Area, Femoral Component Fatigue Strength, Insert Assembly/Disassembly, and Knee Wear.
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.
K994370, K090705, K123457, K131337
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
§ 888.3560 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other. The profiles are black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Ortho Development Corporation Mr. Drew Weaver Director of Regulatory Affairs and Ouality Assurance 12187 South Business Park Drive Draper, Utah 84020
Re: K152169
Trade/Device Name: Balanced Knee® System Trimax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: July 31, 2015 Received: August 4, 2015
Dear Mr. Weaver:
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. Iisting 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/Resourcesfor You/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
Indications for Use
510(k) Number (if known) K152169
Device Name
Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts
Indications for Use (Describe)
The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications:
-
- Loss of knee joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use (Dwelling, STR, MH, Cabin, etc.) | Other: Commercial/Health STR, MH, Cabin, etc. |
|---|---|
| ------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------- |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/fax 553-9993
orthodevelopment.com
Image /page/3/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with three gray arcs above it, followed by the word "ORTHO" in purple, and the word "DEVELOPMENT" in gray below the word "ORTHO". The logo is simple and modern.
Section 5
510(k) Summary
| NAME OF
SPONSOR: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Drew Weaver
Director of Quality Assurance and Regulatory Affairs
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: DWeaver@orthodevelopment.com |
| DATE PREPARED: | July 31, 2015 |
| PROPRIETARY
NAME: | Balanced Knee® System TriMax™ CR Femoral Component
and E-Vitalize® CR and UC Tibial Inserts |
| COMMON NAME: | Total Knee Replacement Prosthesis |
| CLASSIFICATION: | Class II Device |
| PRODUCT
CODES/
REGULATION
DESCRIPTION
AND NUMBER: | JWH - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis (21 CFR 888.3560)
OIY - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis (21 CFR 888.3560) |
| PREDICATE
DEVICES: | Balanced Knee® System (K994370),
Ortho Development Corporation
Balanced Knee® System Ultracongruent Tibial Insert (K090705),
Ortho Development Corporation
Balanced Knee® System High Flex PS (K123457),
Ortho Development Corporation
Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella (K131337)
Ortho Development Corporation |
4
Device Description
The Balanced Knee® System TriMax™ CR femoral component is a highly polished Co-Cr-Mo cruciate retaining femoral component that is designed to accommodate increased range of motion up to 150° of flexion. E-Vitalize® CR and UC tibial inserts are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE (same material as K131337). All components are single use only and the TriMax™ CR femoral component is intended for cemented use only.
The E-Vitalize® CR and UC tibial inserts may be used with TriMax™ CR or BKS CR femoral components. E-Vitalize® CR and UC tibial inserts may also be used with all Ortho Development's tibial tray component offerings. The TriMax™ CR femoral component may be used with all Ortho Development patella component offerings.
Intended Use
The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications:
-
- Loss of knee joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
Technological Characteristics
The predicate devices and TriMax™ CR femoral component and E-Vitalize® CR and UC tibial inserts are based on the following same technological elements:
TriMax™ CR Femoral Component
- Cruciate retaining femoral component design
- Increased range of motion up to 150° flexion
- Cemented fixation of femoral component onto prepared distal femur 0
- Available in a range of sizes to accommodate patient anatomy
- Material: Co-Cr-Mo ASTM F75-12
E-Vitalize® CR Tibial Insert
- Cruciate retaining bearing surface design
- Available in a range of sizes and thicknesses to accommodate patient anatomy
- Use of a locking mechanism to secure tibial insert to tibial tray ●
- Material: Extensively Crosslinked Vitamin E Polyethylene UHMWPE (α-tocopherol) ASTM F2695-12
5
E-Vitalize® UC Tibial Insert
- Ultracongruent bearing surface design
- Available in a range of sizes and thicknesses to accommodate patient anatomy
- Use of a locking mechanism to secure tibial insert to tibial tray
- Material: Extensively Crosslinked Vitamin E Polyethylene UHMWPE (α-tocopherol) ASTM F2695-12 (same material as K131337)
Performance Data
The following non-clinical evaluations were performed and demonstrated substantial equivalence to the predicate devices: Range of Motion, Femorotibial Constraint, Femorotibial Contact Area, Patellofemoral Constraint, Patellofemoral Contact Area, Femoral Component Fatigue Strength, Insert Assembly/Disassembly, and Knee Wear.
Basis for Substantial Equivalence
The TriMax™ CR femoral component and E-Vitalize® CR and UC tibial inserts are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.