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). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augment are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

Device Description

The APEX PS Knee System includes a posterior stabilized Femur Component incorporating a proportionally sized box. The Femur Component has the same bone cuts as the Apex Knee™ System (K060192) with the addition of a cut for the Femur Component box. Femur Components will be available in both cemented and uncemented versions. Size ranges, high flex, and all other design features of the Apex Knee System are retained. The PS Insert has a medio-lateral constraint and utilizes the Apex Knee System Tibial Baseplate. For each PS Insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

AI/ML Overview

The acceptance criteria and study proving the device meets them for the Apex PS Knee™ System are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Apex PS Knee Flexion Range of Motion	Compliance with FDA Class II Special Controls Guidance Document (January 16, 2003) and ASTM F2083-08. Specific range of motion not explicitly stated as an acceptance criterion but implied to be sufficient for function up to 140 degrees (high flexion design feature).	All samples tested met the acceptance criteria.
Contact Area of the Apex PS Knee	Compliance with FDA Class II Special Controls Guidance Document (January 16, 2003) and ASTM F2083-08.	All samples tested met the acceptance criteria.
Tibio-Femoral Constraint of the Apex PS Knee, PS Insert	Compliance with ASTM F2083-08 and ASTM F1223-03.	All samples tested met the acceptance criteria.
Apex Knee PS Tibial Insert Post Strength Testing	Compliance with FDA Class II Special Controls Guidance Document (January 16, 2003).	All samples tested met the acceptance criteria.
Apex PS Knee Patello-Femoral Contact Area and Stability	Compliance with ASTM F2083-08 and FDA Class II Special Controls Guidance Document (January 16, 2003).	All samples tested met the acceptance criteria.
Apex PS Knee Lift-off Comparison to Predicate (DePuy P.F.C. Sigma)	Performance to be comparable or better than the predicate device (DePuy P.F.C. Sigma).	All samples tested met the acceptance criteria.
Apex PS Knee Wear Review	Compliance with ISO 14243-3, ISO 14243-2, and ASTM F1877.	All samples tested met the acceptance criteria.
Apex PS Insert Minimum PS Thickness	Compliance with FDA Class II Special Controls Guidance Document (section 5) and ISO 21536 (2007).	All samples tested met the acceptance criteria.
Apex PS Knee Component Surface Finish Review	Compliance with ISO 7207-2 (1998), ISO 21534 (2007), and ISO 21536 (1998).	All samples tested met the acceptance criteria.
Apex PS Knee Instrument Review	Implied to meet design and performance specifications for instruments.	All samples tested met the acceptance criteria.
Apex PS Knee Tibio-Femoral Conformity Ratios	Implied to meet design specifications.	All samples tested met the acceptance criteria.

Study Proving Device Meets Acceptance Criteria:

The device's performance was evaluated through a series of non-clinical tests as listed above. The provided document states, "All samples tested met the acceptance criteria." This indicates that for each specific test, the Apex PS Knee™ System demonstrated performance within the predefined limits or adherence to the specified standards, thereby proving the device meets its acceptance criteria.

Detailed Information on the Study:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample size for each non-clinical test. It generally states, "All samples tested met the acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance with the standards.
Data Provenance: The tests are non-clinical, likely laboratory-based. The country of origin of the data is not explicitly stated, but given the submitter is OMNIlife science, Inc. in E. Taunton, MA, USA, the testing was likely conducted in the US or by US-affiliated labs. The nature of these tests makes them prospective in that they are conducted specifically to evaluate the new device against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of submission. The "ground truth" for non-clinical performance criteria of a medical device like a knee implant is established by recognized national and international engineering standards (e.g., ASTM, ISO) and FDA guidance documents, not by individual expert consensus on specific cases. The tests are designed to objectively measure physical and mechanical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the evaluation involves objective physical and mechanical tests against predefined standards, not subjective clinical assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The submission is for a knee implant, a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is a physical medical device, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests are the specified engineering and performance criteria established by national and international standards (ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877, ISO 21536, ISO 7207-2, ISO 21534) and relevant FDA Guidance Documents. These standards define acceptable ranges or behaviors for various mechanical and material properties of knee prostheses.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this submission, as it's for a physical device undergoing non-clinical mechanical and material testing, not a machine learning model.

9. How the ground truth for the training set was established

This question is not applicable for the reason stated above.

Summary

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'14

MAR 2 5 2011

510(k) Summary

K102578 - Apex PS Knee ™ System

24 March, 2010

Submitter	OMNIlife science, Inc.50 O'Connell WayE. Taunton MA 02718	Contact	Radhika PondicherryRegulatory Affairs774-226-1852(508) 822-6030 (fax)
Preparation Date	24 March, 2010
Device NameTrade NameCommon/ClassificationName	Apex PS Knee™ SystemKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cementedprosthesisKnee joint patellofemorotibial metal/polymer porous-coated uncementedprosthesis.
Regulatory ClassProduct Code	Class II per 21 CFR §888.3560, §888.3565JWH, MBH
Legally MarketedPredicate Device(s)	• K060192- Apex Knee™ System- cleared 15Jul2006• K073602- Apex Knee™ System Porous Coated FemoralComponents(cementless), cleared 14Feb2008• K950010- Darwin Knee System, cleared 15May1995• K936159- The Natural-Knee® II knee system, cleared 22May2005
Device Description	The APEX PS Knee System includes a posterior stabilized Femur Componentincorporating a proportionally sized box. The Femur Component has the samebone cuts as the Apex Knee™ System (K060192) with the addition of a cut for theFemur Component box. Femur Components will be available in both cementedand uncemented versions. Size ranges, high flex, and all other design features ofthe Apex Knee System are retained. The PS Insert has a medio-lateral constraintand utilizes the Apex Knee System Tibial Baseplate. For each PS Insert, a range ofUHMWPE thicknesses are available to aid in obtaining the proper soft tissuebalance across the knee joint.
Indications for Use	The Apex Knee™ System is intended for use as a primary or revision total kneereplacement. This prosthesis may be used for the following conditions, asappropriate:• 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 porous coated femoral component may be used cemented or uncemented(biological fixation). All other femoral, tibial baseplate and patellar componentsare indicated for cemented use only.The Apex Knee™ Modular Tibia System Tibial Augment are intended to be boltedto the Tibia baseplate and cemented to the prepared tibia.

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K102578 #2/4

Predicate Device Comparison

		Device Comparison
	APEX PS TKA(SubjectDevice)	APEX CR TKA(K060192,K073602)	Darwin KneeSystem(K950010)	Natural Knee II(K936159)
Body Site	Knee	Knee	Knee	Knee
Intended use	Primary andrevision 3compartmentTKA.Is intended foruse as aprimary orrevision totalkneereplacement.	Primary andrevision 3compartmentTKA.Is intended foruse as a primaryor revision totalkneereplacement.	Primary andrevision 3compartmentTKA.Providesseamlesstransitionsbetweenprimary andthe mostdifficultrevision cases.	Primary andrevision 3compartmentTKA.
PatientPopulation	Skeletallymaturepatients.	Skeletallymature patients.	Skeletallymaturepatients.	Skeletallymaturepatients.
Similar Design and Specifications
FemurComponent	FemurComponent:Identical toK060192-noncoated andK073602-coated	FemurComponent:Coated andnoncoated	Surfacepreparationfor use withcement.	FemoralComponent:CSTi™ titaniumon CoCr porouscoating
TibialBaseplate/Component	TibialComponent:Identical toK060192 -noncoated	TibialComponent:Non-coated		TibialComponent:Titanium alloy
Asymmetricfemur,anatomicpatellargroove	YesDesigned with adeep, widepatellar groove	IdenticalDesigned with adeep, widepatellar groove	SimilarDeep singleradiusTrochleargroove,enables thepatella to sitdeeply in thegroove even athigh flexionangles.	SimilarDeepenedtrochleargroovepreventsexcessive loadonthe patellarcomponentwhileprovidingexcellent rangeof motion.
Anatomicasymmetrictibial baseplate	Monobloc: YesModular: No	Monobloc: YesModular: No	No	Yes

Condylar Box(cam) andTibial Post(spine)	Rounded, open,and sloped box- Minimizestibial spineedge loadingand potentialforpolyethylenewear or tibialspine fracture.	Not Applicable,CR device	Squared box(cam)	Squared box(cam)
PS Insert	PS style insertwith cam andpost to controlkinematics	N/A	PS style insertwith cam andpost to controlkinematics	PS style insertwith cam andpost to controlkinematics
PS Insert Post	Yes	No	Yes	Yes
High FlexionDesign Option	Full flexion to140°	Full flexion to140°	Similar	Similar

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K102578 #3/4

Non-Clinical Test Summary

Apex PS Knee Flexion Range of Motion

FDA -Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial . and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA (January 16, 2003)
. ASTM F2083-08- Standard Specification for Total Knee Prosthesis
Contact Area of the Apex PS Knee
FDA -Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial . and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA (January 16, 2003)
ASTM F2083-08- Standard Specification for Total Knee Prosthesis .

Tibio-Femoral Constraint of the Apex PS Knee, PS Insert

ASTM F2083-08- Standard Specification for Total Knee Prosthesis .
ASTM F1223-03- Standard Test Method for Determination of Total Knee . Replacement Constraint

Apex Knee PS Tibial Insert Post Strength Testing

FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial . and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued on January 16, 2003

Apex PS Knee Patello-Femoral Contact Area and Stability

ASTM F2083-08 Standard Specification for Total Knee Prosthesis .
. FDA Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued on January 16, 2003

Apex PS Knee Lift-off Comparison to DePuy P.F.C. Sigma

Apex PS Knee Wear Review

ISO 14243-3- Implants for surgery -- Wear of total knee-joint prostheses -- Part 3: . Loading and displacement parameters for wear-testing machines with

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K102578 * 4/4

displacement control and corresponding environmental conditions for test.
ISO 14243-2- Implants for surgery -- Wear of total knee-joint prostheses -- Part 2: Methods of measurement
ASTM F1877- Standard Practice for Characterization of Particles
Apex PS Insert Minimum PS Thickness
FDA Class II Special Controls Guidance Document (section 5)
ISO 21536 (2007) - Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants

Apex PS Knee Component Surface finish Review

ISO 7207-2 (1998) - Components for partial and total knee joint prostheses -- Part 2: Articulating surfaces made of metal, ceramic and plastics materials
ISO 21534 (2007)- Non-active surgical implants -- Joint replacement implants -- Particular requirements
ISO 21536 (1998)- Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants

Apex PS Knee Instrument Review
Apex PS Knee Tibio-Femoral Conformity Ratios
All samples tested met the acceptance criteria.

Clinical Test Summary	No clinical studies were performed.
Conclusions	The Apex PS Knee System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Omni Life Science, Inc. % Ms. Radhika Pondicherry 50 O'Connell Way East Taunton, Massachusetts 02718

MAR 2 5 2" 11

Re: K102578

Trade/Device Name: Apex PS Knee™ 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: March 18, 2011 Received: March 21, 2011

Dear Ms. Pondicherry:

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

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Page 2 – Ms. Radhika Pondicherry

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 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,

Mark 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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Indications for Use

510(k) Number: K102578

Device Name: Apex PS Knee 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). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.

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

Prescription Use _ X (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)

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A. B. n. h. In no 11
Division Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102578

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.