The Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range of motion up to 150° of flexion. The High Flex PS includes a highly polished Co-Cr-Mo PS femoral component and a compression molded UHMWPE PS tibial insert component. The High Flex PS femoral and insert components may be used in conjunction with the Balanced Knee System (BKS) standard and modular tibial trays, tibial augments, stems, and patellae to complete the semi-constrained modular knee prosthesis.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee System High Flex PS, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Range of Motion	Similar to predicate device LPS-Flex (up to 150° flexion)	Up to 150° flexion; Similar to predicate device, LPS-Flex
Femoral Fatigue	Not explicitly stated, but implies sufficient strength	Improved Fatigue Strength over predicate device, BKS; Sufficient strength to survive in-vivo loading
Femorotibial Constraint	Similar to predicate device BKS	Similar to predicate device, BKS
Femorotibial Contact Area	Similar to predicate device BKS	Similar to predicate device, BKS
Patellofemoral Constraint	Similar to predicate device BKS	Similar to predicate device, BKS
Patellofemoral Contact Area	Similar to predicate device BKS	Similar to predicate device, BKS
PS Spine Fatigue	Not explicitly stated, but implies sufficient strength	Sufficient strength to survive in-vivo loading

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) premarket notification for a medical device (a knee replacement prosthesis). The "Performance Data" section primarily focuses on mechanical testing results rather than clinical study data from a "test set" of patients.

Test Set Sample Size: Not applicable in the context of clinical patient data. The sample sizes for the mechanical tests (e.g., number of components tested for fatigue) are not specified in the provided summary.
Data Provenance: Not applicable for patient data. The "Performance Data" describes laboratory mechanical testing of the device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As described above, this document refers to mechanical testing for device performance, not clinical studies requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert consensus for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the mechanical equivalence of a knee prosthesis to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (knee prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and biomechanical principles, and the performance characteristics of predicate devices. The device's performance is compared against:

Mechanical benchmarks: Sufficient strength for in-vivo loading for fatigue tests.
Predicate device characteristics: Similarity in range of motion, constraint, and contact areas to the Balanced Knee System (BKS) and LPS-Flex predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its mechanical testing, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not a machine learning context, there is no "ground truth for the training set." The performance
evaluation relies on mechanical testing against defined standards and comparison with predicate device characteristics.

Summary

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K12345

MAR 2 2 2013

510(k) Summary

NAME OF SPONSOR:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) CONTACT:	Tom HaueterRegulatory Affairs ManagerTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: thaueter@orthodevelopment.com
DATE PREPARED:	October 29, 2012
PROPRIETARY NAME:	Balanced Knee System High Flex PS
COMMON NAME:	Total Knee Replacement Prosthesis
CLASSIFICATION:	21 CFR 888.3560, Knee joint, patellofemorotibial,polymer/metal/polymer semi-constrained cemented prosthesis,Class II device
DEVICE PRODUCT CODE:	JWH
PREDICATE DEVICES:	Balanced Knee System (K994370), Ortho Development Corp.
	LPS-Flex Fixed Bearing Femoral and Articular Surface Components(K991581), Zimmer

Device Description

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Intended Use

The Balanced Knee System High Flex PS is intended for use in cemented total knee arthroplasty procedures with the following indications:

1. Loss of knee joint configuration and joint function.
1. Osteoarthritis of the knee joint.
ന് 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.

Performance Data

Property	Result
Range of Motion	Up to 150° flexion; Similar to predicate device, LPS-Flex
Femoral Fatigue	Improved Fatigue Strength over predicate device, BKS;Sufficient strength to survive in-vivo loading
FemorotibialConstraint	Similar to predicate device, BKS
FemorotibialContact Area	Similar to predicate device, BKS
PatellofemoralConstraint	Similar to predicate device, BKS
PatellofemoralContact Area	Similar to predicate device, BKS
PS Spine Fatigue	Sufficient strength to survive in-vivo loading

Basis for Substantial Equivalence

Ortho Development believes that the Balanced Knee System High Flex PS is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.

Section 5, 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 22, 2013

Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

Re: K123457

Trade/Device Name: Balanced Knee® System High Flex PS Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 8, 2013 Received: February 21, 2013

Dear Mr. Haueter:

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 enactnent date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the Medical Device Amendments, or to
and Cosmetic Act (Act (Act (Act (Act (Act (Act ) the provisions of the Federal Foo and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug,
You may, therefore, market the devices cubicat of the sproval application (PMA). You may, therefore, market the device, subject to the general controls provisions (Phe
The general controls provisions of the Artical i 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 regulations administered by other registration and listing (21

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Page 2 - Mr. Tom Haueter

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Erin.D.Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Form Ortho Development Balanced Knee® System High Flex PS 510(k)

510(k) Number (if known): K123457

Device Name: Balanced Knee® System High Flex PS

Indications for Use:

The Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures.

Total knee arthroplasty is indicated for the following conditions:

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)

AND/OR '

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey E. Hanley, Ph.D.
Division of Orthopaedic Devices

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.