The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

Device Description

The Apex Knee™ Modular Tibia System is composed of a tibial baseplate that mates with a cap, keel or a stem. Additionally the baseplate may be used with tibial augments and pegs. The components are used together to form a prosthesis for implantation.

AI/ML Overview

This document is a 510(k) summary for the Apex Knee™ Modular Tibia System. It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical test summaries. It explicitly states that no clinical studies were performed for this submission.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for clinical studies cannot be provided, as none were conducted.

The acceptance criteria and study information provided in this document pertain exclusively to non-clinical testing.

Here's the information about the non-clinical tests mentioned:

Acceptance Criteria and Study Information for Non-Clinical Testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Test Name	Acceptance Criteria (Implied)	Reported Device Performance
Packaging Seal per ASTM F1929	Pass (Seal integrity maintained)	Device successfully met the criteria (implied by "The following tests were conducted")
Tray Fatigue Strength Testing per ASTM F1800-07	Pass (Maintain structural integrity under fatigue loading)	Device successfully met the criteria (implied by "The following tests were conducted")
Tray-Augment Fret Testing per ASTM F1800-07	Pass (Minimize micromotion and wear at the interface)	Device successfully met the criteria (implied by "The following tests were conducted")
Tray-Augment Attachment Strength per ASTM F1814-Shear	Pass (Maintain secure attachment under shear forces)	Device successfully met the criteria (implied by "The following tests were conducted")
Tray-Stem Attachment Testing per ASTM F1814: Axial, F1814: Torsion	Pass (Maintain secure attachment under axial and torsional forces)	Device successfully met the criteria (implied by "The following tests were conducted")
Stem and Augment Bolt Retention Testing	Pass (Maintain bolt integrity and retention)	Device successfully met the criteria (implied by "The following tests were conducted")
Modular Stem Femur vs Tibia Loading Comparison per ASTM F1800-07	Pass (Comparable loading characteristics between components)	Device successfully met the criteria (implied by "The following tests were conducted")

Note: The specific quantitative acceptance criteria for each test are not detailed in this summary but are standard for the cited ASTM methods.

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

Sample Size: Not specified in the provided summary for any of the non-clinical tests.
Data Provenance: The tests are described as being conducted "internally" or by a certified lab for the manufacturer, OMNI life science, Inc., based in East Taunton, MA, USA. The data is thus considered prospective as it was generated specifically for this submission.

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

Not applicable. These are engineering/mechanical tests, not clinical evaluations requiring expert interpretation of ground truth data. The "ground truth" is determined by the physical properties and performance measured against the ASTM standard specifications.

4. Adjudication Method for the Test Set

Not applicable, as these are technical performance tests, not clinical evaluations requiring human adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document explicitly states: "No clinical studies were performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

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

7. Type of Ground Truth Used (Non-Clinical)

Engineering specifications and recognized industry standards (ASTM): The "ground truth" for these non-clinical tests is adherence to the performance requirements outlined in the specified ASTM standards (e.g., F1929, F1800-07, F1814).

8. Sample Size for the Training Set

Not applicable. This refers to a medical device, not a machine learning model.

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

Not applicable. This refers to a medical device, not a machine learning model.

Summary

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510(k) Summary

Apex Knee™ Modular Tibia System

Submitter

Contact

OMNI life science, Inc. 50 O'Connel Way E. Taunton, MA 02718

Brandon Molina Regulatory Affairs 774.226.1815 508.822.6030 (fax)

OCT 0 8 2013

Preparation Date

Device Name

Common/Classification Name

Regulatory Class

Product Code

Legally Marketed Predicate Device(s)

Device Description

5/14/2013

Apex Knee™ Modular Tibia System

Knee joint patellofemorotibial polymer/metal/ polymer semi-constrained cemented prosthesis

Class II per 21 CFR §888.3560, 888.3565

JWH, MBH

K101994 - Apex Knee Modular Tibia System cleared September 28, 2010

The Apex Knee Modular Tibia System is composed of a tibial baseplate that mates with a cap, keel or a stem.

Additionally the baseplate may be used with tibial augments and pegs. The components are used together to form a prosthesis for implantation.

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Indications For Use

Predicate Devices Comparison

Non-Clinical Test Summary

The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, . including osteoarthritis and avascular necrosis;
. Rheumatoid arthritis;
. Correction of functional deformity;
. Revision procedures where other treatments or devices have failed:

The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.

The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared The Apex Knee Revision Femur system tibia. augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The subject device is substantially equivalent to its predicate based on comparison of design features, intended use, indications for use, materials, sterilization and shelflife. The safety and effectiveness of the Apex Knee System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

The following tests were conducted:

Packaging Seal per ASTM F1929 .
· Tray Fatigue Strength Testing per ASTM F1800-07
Tray-Augment Fret Testing per ASTM F1800-07 .
. Tray-Augment Attachment Strength testing per ASTM F1814-Shear
. Tray-Stem Attachment Testing per ASTM F1814: Axial, F1814: Torsion
. Stem and Augment Bolt retention testing
Modular Stem Femur vs Tibia Loading Comparison per ASTM F1800-07

No clinical studies were performed.

Clinical Test Summary

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Conclusions

・

. . . . . . . .

. ·

The Apex Knee™ Modular Tibia System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the staff and a serpent intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

October 8, 2013

OMNI Life Science, Incorporated Mr. Brandon Molina Regulatory Affairs 50 O'Connel Way East Taunton, Massachusetts 02718

Re: K131472

Trade/Device Name: Apex Knee" Modular Tibia System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH Dated: August 7, 2013 Received: August 8, 2013

Dear Mr. Molina:

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. Ilisting 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Brandon Molina

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin-DKeith

for

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

Enclosure

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K131472 510(k) Number (if known): Not Known

Device Name: Apex Knee™ Modular Tibia System

The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; .
. Rheumatoid arthritis;
. Correction of functional deformity;
. Revision procedures where other treatments or devices have failed;

The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.

The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Image /page/5/Picture/13 description: The image shows a logo with the text "Casey L. Hanley, Ph.D" on the top line and "Division of Orthopedic Devices" on the second line. There is a horizontal line separating the two lines of text. The logo is stylized with a geometric design that incorporates the letters "FDA".

Page 1 of 1

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.