APEX KNEE SYSTEM, APEX ALL POLY TIBIA

K111062 · Omni Life Science, Inc. · JWH · Jul 13, 2011 · Orthopedic

Device Facts

• Record ID: K111062
• Device Name: APEX KNEE SYSTEM, APEX ALL POLY TIBIA
• Applicant: Omni Life Science, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

Device Story

Apex All Poly Tibia is a semi-constrained monoblock tibial component for total knee arthroplasty; machined from compression-molded UHMWPE. Device functions as posterior cruciate substituting implant; intended for cemented fixation. Used in primary or revision knee replacement surgeries; operated by orthopedic surgeons in clinical/hospital settings. Provides structural replacement for tibial surface; integrates with Apex Knee System femoral and patella components to restore joint function and alleviate pain from degenerative or inflammatory joint disease. Benefits patient through mechanical stabilization of knee joint.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing only, including FEA contact stress, peg stiffness, cement mantle stress, abrasive wear, and insert contact pressure/area testing (ASTM F2083-08).

Technological Characteristics

Material: Compression molded UHMWPE (ASTM F648). Design: Semi-constrained monoblock tibia for posterior cruciate substitution. Sterilization: Ethylene oxide (SAL 10-6), residuals per ISO 10993-7. Shelf life: 5 years. Connectivity: None (mechanical implant).

Indications for Use

Indicated for skeletally mature 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. For cemented use only; must be used with Apex Knee System Femoral and Patella components.

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

• Smith & Nephew Genesis II Total Knee System (K002740)
• Apex Knee™ System (K060192)

Submission Summary (Full Text)

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K111062
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JUL 1 3 2011

Appendix B 510(k) Summary

| Submitter Name | OMNIlife science, Inc.<br>50 O'Connell Way<br>Suite #10<br>East Taunton, MA 02718 | Contact: Christine Nassif<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | Apex All Poly Tibia<br>(subject device) | Smith & Nephew<br>Genesis II Total<br>Knee System<br>[K002740] | Apex Knee™ System<br>[K060192] |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Submission Date: | July 11, 2011 | | Body Site | Knee | Knee | Knee |
| Trade Name | The Apex Knee System, Apex All Poly Tibia | | Intended Use | Primary or revision<br>total knee<br>replacement<br>(cemented) | Primary or revision<br>total knee<br>replacement<br>(cemented) | Primary or<br>revision total<br>knee<br>replacement<br>(cemented<br>for Ultra<br>Congruent) |
| Classification<br>Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented<br>prosthesis | | Patient Population | Skeletally mature<br>patients. | Skeletally mature<br>patients. | Skeletally mature<br>patients. |
| Regulatory Class | Class II per 21 CFR § 888.3560 | | Similar Design and Specifications | | | |
| Product Code | JWH | | Device Design<br>[component] | All Polyethylene<br>Tibia | All Polyethylene<br>Tibia | Apex Knee™ System<br>- Ultra Congruent<br>Tibial Component:<br>Tibial insert<br>Tibial Baseplate<br>(asymmetrical) |
| Device<br>Description | The Apex All Poly Tibia is used as part of a primary or revision cemented total knee<br>implant using established total knee arthroplasty procedures. The All Poly Tibia is<br>intended for use with bone cement, single use implantation and for use only with the<br>Apex Knee™ System Femoral and Patella components. | | Sterility | Ethylene oxide<br>SAL 10-6<br>Residuals: ISO<br>10993-7 | Ethylene oxide | Ethylene oxide<br>SAL 10-6<br>Residuals:<br>ISO 10993-7 |
| | The device is machined from compression molded Ultra High Molecular Weight<br>Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock<br>tibia and designed for posterior cruciate substitution. | | Shelf Life | 5 years from date of<br>manufacture | Not Available | 5 years from date of<br>manufacture |
| Indications for<br>Use | The Apex Knee™ System, Apex All Poly Tibia: | | | MATERIALS and Standards | | |
| | The Apex All Poly Tibia is intended for use as part of a primary or revision total knee<br>replacement. This prosthesis may be used for the following conditions, as appropriate: | | Tibia Component(s) | Machined from<br>compression molded<br>UHMWPE (ASTM<br>F648) | UHMWPE ( ASTM<br>F648) | Machined from<br>compression molded<br>UHMWPE(ASTM<br>F648)<br>CoCr Baseplate |
| | • Non-inflammatory degenerative joint disease, including osteoarthritis and<br>avascular necrosis;<br>• Rheumatoid arthritis;<br>• Correction of functional deformity; | | | | | |
| | • Revision procedures where other treatments or devices have failed. | | | | | |
| | The Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella<br>components. The Apex All Poly Tibia is indicated for cemented use only. | | | | | |
| Legally Marketed<br>Predicate<br>Device(s) | • Smith & Nephew Genesis II Total Knee System, K002740<br>• Apex Knee™ System, K060192 | | | | | |

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# Predicate Device Comparison

Non Clinical The following tests were conducted:

- · FEA Contact Stress Testing
- Stress Analysis
- Peg Stiffness Analysis
- · Cement Mantle Stress Analysis
- FEA Abrasive Wear
- Insert Contact Pressure and Contact AreaTesting (ASTM F2083-08)

All samples tested met the acceptance criteria.

Clinical Test No clinical studies were performed.

Summary

Test Summary

- The Apex Knee™ System, Apex All Poly Tibia is substantially equivalent to the predicate Conclusion devices.

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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 depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

OMNIlife science, Inc. % Ms. Christine Nassif Director, Regulatory Affairs 50 O'Connell Way. Suite #10 E. Taunton, Massachusetts 02767

JUL 13 2011

Re: K111062

Trade/Device Name: Apex Knee System, Apex All Poly Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH

Dated: April 15, 2011 Received: April 18, 2011

Dear Ms. Nassif:

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 - Ms. Christine Nassif

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

Sincerely yours,

ForMark 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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### Appendix A

## Indications for Use Statement

### 510(k) Number: (if known): K111062

#### Device Name: Apex Knee™ System, Apex All Poly Tibia

#### Indications for Use

The Apex Knee™ System, Apex All Poly Tibia:

The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

for M.meikarn

(Division Sign (Off) (Division Signical, Orthopedic, Divisionen Surges and Restorative Devices

K111062

510(k) Number_