K Number

Device Name

APEX PS KNEE SYSTEM

Manufacturer

OMNI LIFE SCIENCE, INC.

Date Cleared

2011-03-25

(198 days)

Product Code

JWH MBH

Regulation Number

888.3560

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K060192, K073602, K950010, K936159

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical knee replacement system and its components, with no mention of AI or ML technology in its design, function, or testing.

Therapeutic

Yes
The device is a total knee replacement system intended to treat conditions like degenerative joint disease and rheumatoid arthritis, which are therapeutic interventions.

Diagnostic

No
The device, the Apex Knee™ System, is a total knee replacement prosthesis used for surgical treatment of knee conditions, not for diagnosing them. Its purpose is to replace a damaged knee joint, not to identify a disease or condition.

SaMD (Software as a Medical Device)

The device description clearly details physical components (Femur Component, PS Insert, Tibial Baseplate, Tibial Augment) and mentions materials (UHMWPE). The performance studies focus on mechanical testing of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for total knee replacement, which is a surgical procedure to replace a damaged knee joint with an artificial one. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
Device Description: The device is described as a system of components (femoral component, tibial baseplate, patellar component, insert) designed to be implanted into the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.

In summary, the Apex Knee™ System is a surgically implanted medical device used for treatment, not a diagnostic device used for testing samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

JWH, MBH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee

Indicated Patient Age Range

Skeletally mature patients.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060192, K073602, K950010, K936159

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

'14

MAR 2 5 2011

510(k) Summary

K102578 - Apex PS Knee ™ System

24 March, 2010

| Submitter | OMNIlife science, Inc.
50 O'Connell Way
E. Taunton MA 02718 | Contact | Radhika Pondicherry
Regulatory Affairs
774-226-1852
(508) 822-6030 (fax) |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------------------------------------------------------------|
| Preparation Date | 24 March, 2010 | | |
| Device Name
Trade Name
Common/Classification
Name | Apex PS Knee™ System
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented
prosthesis
Knee joint patellofemorotibial metal/polymer porous-coated uncemented
prosthesis. | | |
| Regulatory Class
Product Code | Class II per 21 CFR §888.3560, §888.3565
JWH, MBH | | |
| Legally Marketed
Predicate Device(s) | • K060192- Apex Knee™ System- cleared 15Jul2006
• K073602- Apex Knee™ System Porous Coated Femoral
Components(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 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. | | |
| Indications for Use | 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. | | |

K102578 #2/4

Predicate Device Comparison

		Device Comparison
	APEX PS TKA
(Subject
Device)	APEX CR TKA
(K060192,
K073602)	Darwin Knee
System
(K950010)	Natural Knee II
(K936159)
Body Site	Knee	Knee	Knee	Knee
Intended use	Primary and
revision 3
compartment
TKA.
Is intended for
use as a
primary or
revision total
knee
replacement.	Primary and
revision 3
compartment
TKA.
Is intended for
use as a primary
or revision total
knee
replacement.	Primary and
revision 3
compartment
TKA.
Provides
seamless
transitions
between
primary and
the most
difficult
revision cases.	Primary and
revision 3
compartment
TKA.
Patient
Population	Skeletally
mature
patients.	Skeletally
mature patients.	Skeletally
mature
patients.	Skeletally
mature
patients.
Similar Design and Specifications
Femur
Component	Femur
Component:
Identical to
K060192-
noncoated and
K073602-
coated	Femur
Component:
Coated and
noncoated	Surface
preparation
for use with
cement.	Femoral
Component:
CSTi™ titanium
on CoCr porous
coating
Tibial
Baseplate/
Component	Tibial
Component:
Identical to
K060192 -non
coated	Tibial
Component:
Non-coated		Tibial
Component:
Titanium alloy
Asymmetric
femur,
anatomic
patellar
groove	Yes
Designed with a
deep, wide
patellar groove	Identical
Designed with a
deep, wide
patellar groove	Similar
Deep single
radius
Trochlear
groove,
enables the
patella to sit
deeply in the
groove even at
high flexion
angles.	Similar
Deepened
trochlear
groove
prevents
excessive load
on
the patellar
component
while
providing
excellent range
of motion.
Anatomic
asymmetric
tibial baseplate	Monobloc: Yes
Modular: No	Monobloc: Yes
Modular: No	No	Yes

Condylar Box
(cam) and
Tibial Post
(spine)	Rounded, open,
and sloped box

Minimizes
tibial spine
edge loading
and potential
for
polyethylene
wear or tibial
spine fracture. | Not Applicable,
CR device | Squared box
(cam) | Squared box
(cam) | |
| PS Insert | PS style insert
with cam and
post to control
kinematics | N/A | PS style insert
with cam and
post to control
kinematics | PS style insert
with cam and
post to control
kinematics | |
| PS Insert Post | Yes | No | Yes | Yes | |
| High Flexion
Design Option | Full flexion to
140° | Full flexion to
140° | Similar | Similar | |

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

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.

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

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

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)

Page 1 of 1

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

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102578