The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

Device Description

The Apex All Poly Tibia is used as part of a primary or revision cemented total knee implant using established total knee arthroplasty procedures. The All Poly Tibia is intended for use with bone cement, single use implantation and for use only with the Apex Knee™ System Femoral and Patella components.

The device is machined from compression molded Ultra High Molecular Weight Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock tibia and designed for posterior cruciate substitution.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Apex All Poly Tibia" device, which is part of the "Apex Knee™ System." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The information focuses on non-clinical testing for the device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria Met (Yes/No)	Reported Device Performance
FEA Contact Stress Testing	Yes	"All samples tested met the acceptance criteria."
Peg Stiffness Analysis	Yes	"All samples tested met the acceptance criteria."
Cement Mantle Stress Analysis	Yes	"All samples tested met the acceptance criteria."
FEA Abrasive Wear	Yes	"All samples tested met the acceptance criteria."
Insert Contact Pressure and Contact Area Testing (ASTM F2083-08)	Yes	"All samples tested met the acceptance criteria."

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

The document states "All samples tested met the acceptance criteria." however, it does not specify the sample sizes used for any of the non-clinical tests (FEA Contact Stress Testing, Peg Stiffness Analysis, Cement Mantle Stress Analysis, FEA Abrasive Wear, or Insert Contact Pressure and Contact Area Testing).

The data provenance is not explicitly stated beyond being non-clinical tests typically conducted in a lab environment. There is no mention of country of origin of the data, or if it's retrospective or prospective.

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

Since these are non-clinical engineering tests (FEA, stiffness, wear, contact pressure), the concept of "ground truth" established by human experts in the typical clinical sense (like radiologists reading images) does not apply. The "ground truth" for such tests would be based on established engineering principles, material properties, and test standards (e.g., ASTM F2083-08). The document does not mention any human experts establishing ground truth for these specific non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. As these are non-clinical engineering tests with objective measurements against defined acceptance criteria (implicitly derived from engineering standards or predicate device performance), there is no mention of an adjudication method involving human interpretation.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to this submission. The device is a physical knee implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

Engineering principles and simulations: For FEA Contact Stress, Peg Stiffness, Cement Mantle Stress, and FEA Abrasive Wear.
Standardized test methods: Specifically, ASTM F2083-08 for Insert Contact Pressure and Contact Area Testing.
Comparison to predicate device specifications/performance: While not explicitly detailed as "ground truth," the overall goal of the 510(k) is to demonstrate substantial equivalence to predicate devices, implying that the performance of the new device should be within acceptable limits relative to the predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

Summary

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K111062
p11/2

JUL 1 3 2011

Appendix B 510(k) Summary

Submitter Name	OMNIlife science, Inc.50 O'Connell WaySuite #10East Taunton, MA 02718		Apex All Poly Tibia(subject device)	Smith & NephewGenesis II TotalKnee System[K002740]	Apex Knee™ System[K060192]
Submission Date:	July 11, 2011	Body Site	Knee	Knee	Knee
Trade Name	The Apex Knee System, Apex All Poly Tibia	Intended Use	Primary or revisiontotal kneereplacement(cemented)	Primary or revisiontotal kneereplacement(cemented)	Primary orrevision totalkneereplacement(cementedfor UltraCongruent)
ClassificationName	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cementedprosthesis	Patient Population	Skeletally maturepatients.	Skeletally maturepatients.	Skeletally maturepatients.
Regulatory Class	Class II per 21 CFR § 888.3560	Similar Design and Specifications
Product Code	JWH	Device Design[component]	All PolyethyleneTibia	All PolyethyleneTibia	Apex Knee™ System- Ultra CongruentTibial Component:Tibial insertTibial Baseplate(asymmetrical)
DeviceDescription	The Apex All Poly Tibia is used as part of a primary or revision cemented total kneeimplant using established total knee arthroplasty procedures. The All Poly Tibia isintended for use with bone cement, single use implantation and for use only with theApex Knee™ System Femoral and Patella components.	Sterility	Ethylene oxideSAL 10-6Residuals: ISO10993-7	Ethylene oxide	Ethylene oxideSAL 10-6Residuals:ISO 10993-7
	The device is machined from compression molded Ultra High Molecular WeightPolyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblocktibia and designed for posterior cruciate substitution.	Shelf Life	5 years from date ofmanufacture	Not Available	5 years from date ofmanufacture
Indications forUse	The Apex Knee™ System, Apex All Poly Tibia:		MATERIALS and Standards
	The Apex All Poly Tibia is intended for use as part of a primary or revision total kneereplacement. This prosthesis may be used for the following conditions, as appropriate:	Tibia Component(s)	Machined fromcompression moldedUHMWPE (ASTMF648)	UHMWPE ( ASTMF648)	Machined fromcompression moldedUHMWPE(ASTMF648)CoCr Baseplate
	• Non-inflammatory degenerative joint disease, including osteoarthritis andavascular necrosis;• Rheumatoid arthritis;• Correction of functional deformity;
	• Revision procedures where other treatments or devices have failed.
	The Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patellacomponents. The Apex All Poly Tibia is indicated for cemented use only.
Legally MarketedPredicateDevice(s)	• Smith & Nephew Genesis II Total Knee System, K002740• Apex Knee™ System, K060192

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KIII062
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Predicate Device Comparison

Non Clinical The following tests were conducted:

· FEA Contact Stress Testing
- Stress Analysis
- Peg Stiffness Analysis
- · Cement Mantle Stress Analysis
- FEA Abrasive Wear
- Insert Contact Pressure and Contact AreaTesting (ASTM F2083-08)

All samples tested met the acceptance criteria.

Clinical Test No clinical studies were performed.

Summary

Test Summary

The Apex Knee™ System, Apex All Poly Tibia is substantially equivalent to the predicate Conclusion devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

OMNIlife science, Inc. % Ms. Christine Nassif Director, Regulatory Affairs 50 O'Connell Way. Suite #10 E. Taunton, Massachusetts 02767

JUL 13 2011

Re: K111062

Trade/Device Name: Apex Knee System, Apex All Poly Tibia 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: April 15, 2011 Received: April 18, 2011

Dear Ms. Nassif:

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, 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Christine Nassif

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,

ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix A

Indications for Use Statement

510(k) Number: (if known): K111062

Device Name: Apex Knee™ System, Apex All Poly Tibia

Indications for Use

The Apex Knee™ System, Apex All Poly Tibia:

The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

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)

for M.meikarn

(Division Sign (Off) (Division Signical, Orthopedic, Divisionen Surges and Restorative Devices

K111062

510(k) Number_

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.