The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation, with the option of using a porous coated femoral component for uncemented or cemented fixation. 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; .
Congenital dislocation; ●
Revision procedures where other treatments or devices have failed. .

Device Description

The Apex Knee System Porous Coated Femoral Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome femoral components have a sintered porous coating (ASTM F1377). Fixation of the femoral component is achieved using either PMMA bone cement or by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System consists of a range of sizes of femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a sizefor-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial 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 provided text describes a 510(k) premarket notification for the Apex Knee System Porous Coated Femoral Components. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove performance against specific acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details will not be explicitly found in this document.

However, I can extract the relevant information from the document that addresses the comparison to predicate devices, which is the basis for this 510(k) clearance.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is the claim of equivalence.

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance
Substantial Equivalence to Predicate Devices	Claimed to be substantially equivalent to: - Apex Knee System (K060192) for cemented components - Sigma Cruciate-Retaining Porocoat® Femoral Components (K062654) for porous coated components
Identical Intended Use	Indications for Use are identical to the predicate Apex Knee System, with the added option of uncemented fixation for the porous coated femoral component.
Similar Design Features	Similar design (asymmetric femur, anatomic patella groove, metal-backed UHMWPE tibial component, patella design) to predicate devices. The key difference is the addition of a porous coating.
Similar Materials	Femoral component: Cobalt chrome.Porous coating: Sintered cobalt chrome (same as DePuy predicate and Sponsor's K031110)
Same Manufacturing, Packaging, Sterilization Methods	Identical to the predicate Apex Knee System (K060192).

2. Sample size used for the test set and the data provenance:

Not applicable. This submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to existing predicate devices rather than new clinical testing against a specific test set. No new clinical study data or patient samples are presented for this purpose in the document. The 'test set' in this context would be the comparison against specifications and characteristics of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As this is a 510(k) based on substantial equivalence, there is no "test set" in the sense of clinical data requiring expert review for ground truth. The evaluation is against the features and performance of predicate devices as described in their own 510(k)s or regulatory clearances.

4. Adjudication method for the test set:

Not applicable. No clinical data test set requiring adjudication is presented.

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:

Not applicable. This device is a total knee replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.

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

Not applicable. This device is a total knee replacement prosthesis and does not involve an algorithm or AI component.

7. The type of ground truth used:

Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) hinges on the established characteristics, performance, and regulatory clearances of the legally marketed predicate devices. The "truth" is that the new device is functionally and materially similar enough to the predicates to warrant substantial equivalence.

8. The sample size for the training set:

Not applicable. This device is a physical medical implant, not an AI model requiring a training set.

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

Not applicable. See point 8.

Summary

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Apex Knee System

Device Name

December 20, 2007

Submitter: OMNI life science™, Inc. 175 Paramount Drive

Contact: Mr. William S. McCallum

Raynham, MA 02767

Director of Requlatory and Quality Systems (508) 824-2444 (voice) (508) 822-6030 (fax)
FEB 14 23

Proprietary Name:	Apex Knee System Porous Coated Femoral Components
Common Name:	Total Knee Replacement Prosthesis
Classification Names:	Prosthesis, knee, patellofemorotibial, semi-constrained,cemented, polymer/metal/polymerProsthesis, knee, patellofemorotibial, semi-constrained,uncemented, polymer/metal/polymer
Regulatory Classes:	Class II per 21 CFR §888.3560Class II (special controls) per 21 CFR §888.3565
Product Codes:	JWH, MBH

3. Intended Use

. 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. .

4. Device Description

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5. Predicate Device Comparison

Substantial equivalence is claimed to the Apex Knee System (K060192), distributed by OMNI life science, Inc., and the Sigma Cruciate-Retaining Porocoat® Femoral Components distributed by DePuy Orthopedics (K062654). The following table summarizes the similarities and differences between the subject uncemented femoral components of the Apex Knee System and these predicate devices:

	Apex KneePorous CoatedFemoralComponents	Apex KneeCementedFemoralComponents(K060192)	Sigma*Porocoat®FemoralComponents(K062654)
INTENDED USE
Primary and revision, 3	Yes, cemented or	Yes, cemented	Yes, cemented or
compartment	uncemented		uncemented
DESIGN
Porous coated	Yes	No	Yes
Asymmetric femur,	Yes	Yes	Yes
anatomic patella groove
Anatomic (asymmetric)	Yes	Yes	No
tibial tray
Metal-backed UHMWPE	Yes	Yes	Yes
tibial component
Tibial insert designs	CR and Ultra	CR and Ultra	CR ("Curved")
Tibial tray distal features	Central post and	Central post and	Central post and 2
	2 keels	2 short keels	short keels
Patella design	Round, single	Round, single	Round, single
	radius dome, 3	radius dome, 3	radius dome, 3
	pegs	pegs	pegs
MATERIALS
Femoral component	Cobalt chrome	Cobalt chrome	Cobalt chrome
Femoral porous coating	Yes, sintered	No	Yes, sintered
	cobalt chrome		cobalt chrome

The only change to the Sponsor's predicate Apex Knee System (K060192) is the addition of a sintered cobalt chrome porous coating to the femoral components. This porous coating is similar to the sintered cobalt chrome porous coating on the predicate DePuy femoral components, and has the same bead configuration (sizes and shapes) as the Sponsor's Apex Modular Acetabular Cup (K031110). All other materials, designs, and manufacturing, packaging, and sterilization methods are identical to the predicate Apex Knee System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular fashion around the eagle.

Public Health Service

FEB 14 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OMNI life science, Inc. % Mr. William McCallum Director, Regulatory and Quality 175 Paramount Drive, Suite 302 Raynham, Massachusetts 02767

Re: K073602

Trade/Device Name: Apex Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: January 25, 2008 Received: January 28, 2008

Dear Mr. McCallum:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. William McCallum

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullens

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K073602

Device Name: OMNI life science Apex Knee System

Indications For Use:

The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended fixation, with the option of using a porous coated femoral component for uncemented or cemented fixation. 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; .
Congenital dislocation; ●
Revision procedures where other treatments or devices have failed. .

Prescription Use X (Per 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)

Chubare BouellD
Page 1 of 1

Restorative, Division of Ge and Neurological Devices

510(k) Number K073602

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.