APEX KNEE SYSTEM

K060192 · Omni Life Science, Inc. · JWH · Jun 15, 2006 · Orthopedic

Device Facts

• Record ID: K060192
• Device Name: APEX KNEE SYSTEM
• Applicant: Omni Life Science, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 and single use implantation. 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. .

Device Story

Apex Knee System is a modular, cemented, single-use total knee prosthesis. Components include cobalt chrome femoral parts, UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy locking bolt. Surgeon selects component sizes to match patient anatomy; tibial inserts available in cruciate retaining (CR) or ultra-congruent (Ultra) designs to balance soft tissue. Device is implanted by orthopedic surgeons in clinical/OR settings. System provides mechanical replacement of knee joint surfaces to restore function and alleviate pain associated with degenerative or inflammatory joint disease.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Cobalt chrome femoral/tibial components, titanium alloy bolt, GUR 1020 UHMWPE inserts/patella. Design: Modular, semi-constrained, cemented. Tibial tray features central post and two keels. Sterilization: Ethylene oxide (EtO). Connectivity: None (mechanical device).

Indications for Use

Indicated for primary or revision total knee replacement in patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, or functional deformity requiring correction. Intended for cemented, single-use implantation.

Regulatory Classification

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).

Predicate Devices

• P.F.C. Sigma Fixed Bearing Cruciate-Retaining Knee System (K943462, K961685)
• Natural-Knee II (K973412, K021578)

Submission Summary (Full Text)

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K060192

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# EXHIBIT A 510(K) Summary

# Apex Knee System

### January 23, 2006

1. Submitter: OMNI life science™, Inc. 1390-A Decision Street Vista, CA 92081

- Contact: Ms. Christine Otis Requlatory and Quality Systems [phone] x134 (voice) [phone] (fax)
#### 2. Device Name

| Proprietary Name: | Apex Knee System |
|----------------------|------------------------------------------------------------------------------------------|
| Common Name: | Knee prosthesis, cemented |
| Classification Name: | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
| Regulatory Class: | Class II per 21 CFR §888.3560 |

#### 3. Intended Use

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 and single use implantation. 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. .

#### 4. Device Description

The Apex Knee System is a primary or revision total knee replacement. This knee replacement is intended for use with bone cement and single use implantation. This knee system consists of a range of sizes of cobalt chrome 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 size-for-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.

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### 5. Predicate Device Comparison

Substantial equivalence is claimed to the P.F.C. Sigma Fixed Bearing Cruciate-Substantial equivalence is clauned to the 1. . . . . Relaining Rilee System uistibuted by Dr. ay Orthopsterior distributed by Zimmer, Inc. The Cruciale Retaining and Postoner Stablishes and differences between the Apex Knee System and these predicate devices:

| | Apex Knee | P.F.C. ® Sigma*<br>(K943462, K961685) | Natural-Knee® II*<br>(K973412, K021578) |
|--------------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision, 3<br>compartment, cemented | Yes | Yes | Yes |
| DESIGN | | | |
| Porous coated | No | No | No |
| Asymmetric femur,<br>anatomic patella groove | Yes | Yes | Yes |
| Anatomic (asymmetric)<br>tibial tray | Yes | No | Yes |
| Metal-backed UHMWPE<br>tibial component | Yes | Yes | Yes |
| Tibial insert designs | CR and Ultra | CR ("Curved") | CR ("Congruent")<br>and Ultra<br>("Ultracongruent") |
| Tibial tray distal features | Central post and<br>2 keels | Central post and<br>2 short keels | Central post, 4<br>keels, and 4 pegs |
| Patella design | Round, single<br>radius dome, 3<br>pegs | Round, single<br>radius dome, 3<br>pegs | Round, partial<br>dome, 3 pegs |
| MATERIALS | | | |
| Cobalt chrome femur | Yes | Yes | Yes |
| CoCr tibial tray | Yes | No - ti alloy | Yes |
| All-poly patella | Yes | Yes | Yes |
| UHMWPE | Sheet molded<br>GUR 1020 | Sheet molded<br>GUR 1020 | Sheet molded<br>GUR 1020 |
| Highly cross-linked<br>UHMWPE (sterilization) | No (EtO) | No (y irradiation<br>in vacuum) | No (y irradiation in<br>nitrogen) |

The most significant difference between these devices is that the Apex Knee employs The most sighthoum unforonoo bother tibial tray using two parallel "dovetail" rails on INVI E «blar hoons the predicate devices employ UHMWPE inserts that are snapfit into the tibial tray.

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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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 2006

OMNI life science, Inc. % Edward J. Cheal, Ph.D. Vice President of Research 175 Paramount Drive, Suite 302 Raynham, Massachusetts 02767

Re: K060192

Trade/Device Name: Apex 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 Dated: May 15, 2006 Received: May 16, 2006

Dear Dr. Cheal:

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 - Edward J. Cheal, Ph.D.

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 logally marketed predicate device results in a classification for your device and thus, permitts 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ohtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.

Sincerely yours,

Barbara Mnechuk

Mark N. Melkerson, M.S. 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):

Device Name: 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 for cemented fixation and single use implantation. 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.

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)

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(Division Sign-Division of General, estorative. and Neurological De

510(k) Number.***_***_

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