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 is to be used uncemented (biological fixation).
All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.

Device Description

The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Apex Knee™ System," a knee joint prosthesis. However, the document does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device.

The document is a submission for a physical medical device (a knee implant), not an AI device. Therefore, the questions related to AI device performance (e.g., number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical implant, primarily through material characterization, mechanical testing, and biocompatibility testing. The "acceptance criteria" discussed are mainly related to the performance standards for the implant materials and design, such as wear testing, strength testing, and sterility assurance levels.

Here's a breakdown of what is and is not in the provided text:

Information NOT Found (as it pertains to an AI device):

1. Table of acceptance criteria and reported device performance for an AI device: Not present. The acceptance criteria relate to mechanical and biological properties of the implant.
2. Sample size and data provenance for an AI test set: Not applicable. The "test set" refers to mechanical samples and animal models, not patient data for AI evaluation.
3. Number of experts and qualifications for AI ground truth: Not applicable. Ground truth for an AI device (e.g., image annotation) is not relevant here.
4. Adjudication method for an AI test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI: Not applicable.
6. Standalone (algorithm only) performance for AI: Not applicable.
7. Type of ground truth for an AI device: Not applicable. Ground truth here refers to engineering specifications and biological response, not diagnostic labels for AI.
8. Sample size for an AI training set: Not applicable.
9. How ground truth for an AI training set was established: Not applicable.

What the document does provide regarding the physical device's "studies":

The document broadly mentions "non-clinical testing" conducted to demonstrate the safety and effectiveness and substantial equivalence of the modified Apex Knee™ System. These tests are the "study" proving the device meets its acceptance criteria (though not presented in the AI-specific format requested).

Testing for Pegged Tibial Baseplates:
- FEA (Finite Element Analysis) simulation
- Peg location templating study
Testing for ECiMa Tibial Inserts & Patellae:
- Material characterization
- PS (Posterior Stabilized) post strength testing
- Insert disassembly strength testing
- Wear testing
Biocompatibility Testing for ECiMa material:
- Intramuscular implantation in animal models
- Implant toxicity and subcutaneous implantation in animal models
Sterility: Validated sterilization process using ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10-6. Endotoxin testing via Limulus amebocyte lysate (LAL) on a quarterly rotating basis for product groups.

Conclusion:

This document is a regulatory submission for a physical knee implant and does not contain the specific information requested regarding AI device acceptance criteria and study methodologies. The "studies" mentioned are engineering and biological tests demonstrating the physical device's performance and safety.

Summary

{0}------------------------------------------------

April 2, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features a stylized depiction of human figures, while the FDA part includes a blue square with "FDA" in white and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

OMNIlife science Dipti Dharia Chief Quality, Regulatory, & Clinical Officer 480 Paramount Drive Raynham, Massachusetts 02767

Re: K201611/S001

Trade/Device Name: Apex Knee™ System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: February 19, 2021 Received: March 4, 2021

Dear Dipti Dharia:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K201611

Device Name Apex Knee™ System

Indications for Use (Describe)

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 is to be used uncemented (biological fixation).

All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.

The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.

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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for OMNI. The logo consists of a circular graphic on the left and the word "OMNI" on the right. The circular graphic is blue and green and appears to be a stylized representation of a person. Below the word "OMNI" is the phrase "Engineering Orthopaedic Innovation".

510(k) Summary

TABLE 1: 510(k) SUMMARY
Date Summary Prepared	06/12/2020
Manufacturer/Distributor/Sponsor	OMNIlife Science480 Paramount DriveRaynham, MA 02767
510(k) Contact	Dipti DhariaChief Quality, Regulatory & Clinical OfficerCorin Ltd.,480 Paramount DriveRaynham, MA 02767Telephone: +1-732-754-5466Email: Dipti.Dharia@coringroup.comSecondary Contact:Jack LiangSenior Regulatory Affairs SpecialistCorin Ltd / Corin Australia+61 2 9497 7400Jack.Liang@coringroup.com
Trade Name	Apex Knee™ System
Common Name	prosthesis, knee, patellofemorotibial, semi-constrained,cemented, polymer/metal/polymerprosthesis, knee, patello/femorotibial, semi-constrained,uncemented, porous, coated
Classification	21 CFR 888.3560. Class II. Knee jointpatellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. JWH21 CFR 888.3565. Class II. Knee jointpatellofemorotibial metal/polymer porous-coateduncemented prosthesis. MBH
Predicate Device	OMNI TiN Coated Apex Knee™ System- K191765
Purpose of Submission	This traditional 510(k) premarket notification is beingsubmitted to obtain clearance for the modifications tothe Apex Knee™ System to expand OMNI's productoffering for total knee arthroplasty.
Indications for Use	The Apex Knee™ System is intended for use as aprimary or revision total knee replacement. Thisprosthesis may be used for the following conditions, asappropriate:Non-inflammatory degenerative joint disease,including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments ordevices have failed; The porous coated femoral component may be usedcemented or uncemented (biological fixation).The Porous coated tibial baseplate is to be useduncemented (biological fixation).All other femoral, tibial baseplate, and patellarcomponents are indicated for cemented use only.The Apex Knee™ Modular Tibia System TibialAugments are intended to be bolted to the Tibiabaseplate and cemented to the prepared tibia.
Device Description	The proposed devices are intended to be used forprimary and revision total knee replacement.The Pegged Tibial Baseplates offer additional torsionalstability by adding pegs to the posterior end of thedevice. The material of the proposed Pegged TibialBaseplates are Cobalt Chrome, CoCr (ASTM F75).The ECiMa tibial inserts are machined fromcompression molded highly crosslinked polyethylenewith Vitamin E (VE-XLPE) and attaches to the cobaltchrome tibial baseplate via dovetails and a retaining
Engineering Orthopaedic Innovation
Sterility and Biocompatibility	The proposed devices undergo the same validatedsterilization process, using ethylene oxide (EO), as thepredicate devices (K060192, K102578, K111184,K112891) under the sterility assurance level (SAL) of10-6. All ethylene oxide residuals are monitored andwell below standard limits.In addition, OMNI has developed a plan to testendotoxins on all OMNIlife science device groupsthrough Limulus amebocyte lysate (LAL) testing.Products have been segregated into product familiesbased on manufacturing process and material type andhave generated 8 product groups that will be tested forendotoxins on a quarterly basis on a yearly rotation, andthe subject devices are included in one of the productgroups. Product will not be released if the 4 EU/devicelimit is exceeded.
Substantial Equivalence Summary	The proposed devices with modifications aresubstantially equivalent to the existing Apex Knee™System cleared in K191765 as the basic design,interface, fundamental technology and intended use arethe same.The use of the new Apex Knee™ System componentswith the existing knee components do not introduce anynew risks of safety or efficacy.Tibial Baseplate:In addition to the testing performed for the Apex KneeSystem, non-clinical testing specifically for the PeggedPorous Coated Cementless Tibial Baseplates includeFEA simulation and peg location templating study.The results of the testing show that the Apex KneePegged Porous Coated Cementless Tibial Baseplates are
	safe and effective for the proposed indications and issubstantially equivalent to the predicate devices.The justifications are described in Section 10, DeviceDescription.
	ECiMa Tibial Inserts & Patellae
	In addition to the testing already performed for the ApexKnee System, non-clinical testing was conductedspecifically for the ECiMa Tibial Inserts & Patellae.These tests include:• material characterization,• PS post strength testing,• insert disassembly strength testing,• wear testing.
	Biological testing of the ECiMa material was conductedfor biocompatibility. These tests include:• intramuscular implantation in animal models,• implant toxicity and subcutaneous implantation inanimal models.
	The results of the testing show that the Apex KneeECiMa Tibial Inserts & Patellae are safe and effectivefor the proposed indications and is substantiallyequivalent to the predicate devices.
	Based on the design, fundamental technology, material,intended use and technological characteristics,OMNIlife science believes the proposed Apex KneeTMSystem devices to be substantially equivalent to legallymarketed predicates.
Conclusion Statement	The conclusions drawn from the nonclinical testsdemonstrate that the devices are safe, as effective, andperform as well as or better than the legally marketeddevice

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for OMNI. The logo consists of a blue and green circular graphic to the left of the word "OMNI" in large, bold, blue letters. Below the word "OMNI" is the text "Engineering Orthopaedic Innovation" in a smaller font size. The logo is clean and professional, and the colors are eye-catching.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for OMNI Engineering Orthopaedic Innovation. The logo features a stylized human figure inside of a circle on the left. The word "OMNI" is in large, bold, blue letters to the right of the figure. Below the word "OMNI" is the phrase "Engineering Orthopaedic Innovation" in a smaller font.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for OMNI. The logo consists of a blue and green circular design on the left, followed by the word "OMNI" in large, bold, blue letters. Below the word "OMNI" is the text "Engineering Orthopaedic Innovation" in a smaller font.

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.