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:

1. Loss of knee joint configuration and joint function.
1. Osteoarthritis of the knee joint.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts. It does not describe a study involving detailed acceptance criteria, sample sizes, expert adjudication, or AI performance metrics as requested in the prompt. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on design, materials, and mechanical performance rather than clinical study data from human subjects or AI-driven analysis.

Therefore, I cannot extract the requested information from the provided text. The document details the product description, intended use, technological characteristics, and predicate devices, along with a list of non-clinical evaluations performed. However, it does not provide:

A table of acceptance criteria and reported device performance: The document mentions "non-clinical evaluations were performed and demonstrated substantial equivalence," but does not list specific acceptance criteria or corresponding performance values for these evaluations.
Sample size used for the test set and data provenance: The document refers to "non-clinical evaluations" but does not specify test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
Number of experts and their qualifications for ground truth: This information is irrelevant for a non-clinical evaluation submission.
Adjudication method for the test set: Irrelevant for non-clinical evaluations.
Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human reader improvement with AI: This is not an AI device, so an MRMC study related to AI assistance is not applicable.
Standalone (algorithm only) performance: This is not an AI device, so standalone algorithm performance is not applicable.
Type of ground truth used: Irrelevant for non-clinical mechanical testing.
Sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The "Performance Data" section merely states: "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." This indicates that mechanical and material testing was conducted to show the new device performs similarly to existing, legally marketed devices, which is the basis for 510(k) clearance.

Summary

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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

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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/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

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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)

1. Loss of knee joint configuration and joint function.
1. Osteoarthritis of the knee joint.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

Type of Use (Select one or both, as applicable)
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Residential Use (Dwelling, STR, MH, Cabin, etc.)	Other: Commercial/Health STR, MH, Cabin, etc.
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|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 OFSPONSOR:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) CONTACT:	Drew WeaverDirector of Quality Assurance and Regulatory AffairsTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: DWeaver@orthodevelopment.com
DATE PREPARED:	July 31, 2015
PROPRIETARYNAME:	Balanced Knee® System TriMax™ CR Femoral Componentand E-Vitalize® CR and UC Tibial Inserts
COMMON NAME:	Total Knee Replacement Prosthesis
CLASSIFICATION:	Class II Device
PRODUCTCODES/REGULATIONDESCRIPTIONAND NUMBER:	JWH - Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis (21 CFR 888.3560)OIY - Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis (21 CFR 888.3560)
PREDICATEDEVICES:	Balanced Knee® System (K994370),Ortho Development CorporationBalanced Knee® System Ultracongruent Tibial Insert (K090705),Ortho Development CorporationBalanced Knee® System High Flex PS (K123457),Ortho Development CorporationBalanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella (K131337)Ortho Development Corporation

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Device Description

Intended Use

1. Loss of knee joint configuration and joint function.
1. Osteoarthritis of the knee joint.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. 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

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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.

Regulation Number and Section

§ 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.