TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

K094017 · Omni Life Science, Inc. · JWH · Mar 5, 2010 · Orthopedic

Device Facts

• Record ID: K094017
• Device Name: TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
• Applicant: Omni Life Science, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System 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

The Apex Knee System Tibial Baseplate Augment consists of metal spacers used in total knee replacement surgery. These augments are cemented beneath the tibial tray using PMMA bone cement to provide additional support or fill gaps. The device is used by orthopedic surgeons in a clinical/OR setting. By providing structural augmentation, the device assists in restoring joint function and stability in patients undergoing primary or revision knee arthroplasty. The output is a physical implant that becomes a permanent part of the patient's knee construct, facilitating improved clinical outcomes for patients with degenerative joint disease or failed prior procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Testing was conducted to ensure usability and function of the tibial baseplate augments.

Technological Characteristics

Manufactured from Ti-6Al-4V alloy. Designed for use with the Apex Knee System. Available in five sizes (8mm thickness). Sterilized via ethylene oxide (EO) to a sterility assurance level (SAL) of 10^-6. Shelf life is 5 years.

Indications for Use

Indicated for patients requiring primary or revision total knee replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or failed previous treatments. Intended for single-use, cemented fixation.

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

• Apex Knee System (K060192)
• Tibial Spacer for the Natural Knee (K031183)

Submission Summary (Full Text)

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## 510 (k) Summary

## For the OMNI life science Apex Knee System Tibial Baseplate Augment

| Submitter | OMNI life science, Inc.<br>50 O'Connell Way #10<br>E. Taunton, MA 02718 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MAR - 5 2010 |
| Contact Person | Robert Zoletti<br>OMNI life science, Inc.<br>50 O'Connell Way #10<br>E. Taunton, MA 02718<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date | February 26, 2010 |
| Common Name | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,<br>polymer/metal/polymer |
| Trade Name | Apex Knee System Tibial Baseplate Augment |
| Classification Name | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,<br>polymer/metal/polymer |
| Classification Panel | Orthopedic (OR) |
| Regulatory Class | Class II per 21 CFR 888.3560 |
| Product Code | JWH |
| Legally Marketed | Apex Knee System K060192 |
| Predicate Device(s) | Tibial Spacer for the Natural Knee K031183 |
| Device Description | The Augments are used as optional spacers and are cemented below the<br>Tibial Tray using PMMA bone cement.<br><br>The Tibial Baseplate Augment is available in the following Sizes:<br>• Size 1 x 8mm<br>• Size 2 x 8mm<br>• Size 3 x 8mm<br>• Size 4 x 8mm<br>• Size 5 x 8mm |
| Indications for Use | The Apex Knee System Tibial Baseplate Augment is intended for use with<br>the Apex Knee System as a primary or revision total knee replacement. This<br>knee replacement system is intended for cemented fixation and single use<br>implantation. This prosthesis may be used for the following conditions, as<br>appropriate:<br>• Non-inflammatory degenerative joint disease, including |
| • | Rheumatoid arthritis; |

osteoarthritis and avascular necrosis;

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- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed. .

and the comments of the comments of

| Technological<br>Characteristics | The Augments are manufactured from Ti-6Al-4V and designed for use with<br>the Apex Knee System cleared in K060192. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence<br>Comparison | Performance testing, design comparisons, and functional analysis<br>conducted on the Augments demonstrate that they are equivalent to the<br>predicate devices. |
| Clinical and Non-Clinical<br>Data | The Apex Tibial Baseplate Augments were bench tested to assure usability<br>and function. |
| Packaging and<br>Sterilization | Packaged Sterile<br>EO Sterilized, SAL 10-6<br>Shelf life is 5 years from date of manufacture |

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

MAR - 5 2010

OMNI Life Science, Inc. % Mr. Robert Zoletti 50 O'Connell Way #10 East Taunton, Massachusetts 02718

Re: K094017

Trade/Device Name: Apex Knee System Tibial Baseplate Augment Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemoraltibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH

Dated: February 12, 2010 Received: February 16, 2010

Dear Mr. Zoletti:

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 - Mr. Robert Zoletti

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/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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ababare Bryent

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: K094017

Device Name: Apex Knee™ System Cemented Tibial Augment

## Indications for Use

The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System 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 _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Orita for mxn

(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices

510(k) Numbe

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OMNI life science

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