APEX REVISION KNEE SYSTEMS

K112891 · Omni Life Science, Inc. · JWH · Feb 29, 2012 · Orthopedic

Device Facts

• Record ID: K112891
• Device Name: APEX REVISION KNEE SYSTEMS
• Applicant: Omni Life Science, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 29, 2012
• 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 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). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur.

Device Story

Apex Revision Knee System is a semi-constrained total knee prosthesis; includes revision femoral component, PS-R insert, retaining bolts, femoral augments, and femoral stems. Designed for use in revision total knee replacement procedures; compatible with existing modular tibial baseplates and patella components. Revision femoral component features proportionally sized box higher than Apex PS design; maintains bone cuts consistent with Apex CR and PS systems. Components are surgically implanted by orthopedic surgeons in a hospital setting. Augments bolt to femoral component; cemented to prepared femur. System provides mechanical stability and joint function restoration for patients with failed prior treatments or severe joint disease.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing, including ASTM F2083-08 (Total Knee Prosthesis), ASTM F1223-03 (Constraint), ISO 14243-2/3 (Wear), and ASTM F1877 (Particle Characterization). Testing confirmed that the revision components meet performance criteria for stability, contact area, and wear resistance.

Technological Characteristics

Semi-constrained knee prosthesis; metal/polymer construction. Complies with ASTM F2083-08, ASTM F1223-03, ISO 14243-2, ISO 14243-3, and ASTM F1877. Features include modular femoral augments and stems; porous coating options for biological fixation or cemented use. Mechanical assembly via bolting and cementation.

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 failure of previous treatments/devices.

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)
• Apex PS Knee™ System (K102578)
• Darwin Knee System (TC3) (K952830)

Reference Devices

• Modular Tibial Baseplates (K101994)
• Patella component (K060192)

Submission Summary (Full Text)

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## FEB 2 9 2012

## 510(k) Summary

| Apex Revision Knee ™ System | | 29 September, 2011 | | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-----------------------------------------------------------------------------------|--|
| Submitter | OMNIlife science, Inc.<br>50 O'Connell Way Suite #10<br>E. Taunton MA 02718 | Contact | Radhika Pondicherry<br>Regulatory Affairs<br>774-226-1852<br>[phone] (fax) | |
| Preparation Date | 29 September, 2011 | | | |
| Trade Name<br>Common/Classification<br>Name | Apex Revision Knee System<br>Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis<br>Knee joint patellofemorotibial metal/polymer porous-coated uncemented<br>prosthesis. | | | |
| Regulatory Class<br>Product Code | Class II per 21 CFR §888.3560, 21 CFR §888.3565<br>JWH, MBH | | | |
| Legally Marketed<br>Predicate Device(s) | • K060192- Apex Knee™ System- cleared 15Jul2006<br>• K102578- Apex PS Knee™ System, cleared 25May2011<br>• K952830- Darwin Knee System (TC3) cleared 18Jan1996 | | | |
| Device Description | The Apex Revision Knee System includes the Revision Femoral Component,<br>PS-R Insert, Retaining bolts, Femoral Augments and Femoral Stems. The<br>Revision system is compatible with the previously cleared Modular Tibial<br>Baseplates (K101994) and Patella component (K060192). The PS-R Insert has<br>one level of medio-lateral constraint. The Revision Femoral component<br>incorporates a proportionally sized box that is higher than the Apex PS Knee<br>design (K102578). The Revision Femoral Component has the same bone cuts<br>as the Apex CR Knee System and the Apex PS Knee System (K060192 and<br>K102578). Size ranges, high flex and all other key design features of the Apex<br>CR Knee System (K060192) have been retained in the Apex Revision Knee<br>System. The Femoral Augments and Femoral Stems are available for use with<br>the Revision Femoral Component. | | | |
| Indications for Use | The Apex Knee™ System is intended for use as a primary or revision total<br>knee replacement. This prosthesis may be used for the following conditions,<br>as appropriate:<br>• Non-inflammatory degenerative joint disease, including osteoarthritis<br>and avascular necrosis;<br>• Rheumatoid arthritis;<br>• Correction of functional deformity;<br>• Revision procedures where other treatments or devices have failed;<br>The porous coated femoral component may be used cemented or<br>uncemented (biological fixation). The porous coated tibial baseplate | | | |

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| component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur. | |
| Predicate Device<br>Comparison | The Apex Revision Knee System is manufactured, packaged, and sterilized using equivalent materials and processes as the predicates. The subject device(s) is also substantially equivalent to its predicate(s) based on comparison of design features, intended use, and indications for use. The safety and effectiveness of the Revision Knee is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. |
| Non-Clinical Test<br>Summary | Revision Femur Stem Location Analysis<br>Apex PS Knee Revision Femur Flexion Range of Motion 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 Apex Revision Knee Lift-off (Jump Height) Comparison<br>Tibio-Femoral Constraint of the Apex PS Knee, Revision femur and PS-R Insert ASTM F2083-08- Standard Specification for Total Knee Prosthesis ASTM F1223-03- Standard Test Method for Determination of Total Knee Replacement Constraint Contact Area of the Apex PS Revision Knee 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 Revision Knee Insert post Strength 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 Knee Stem Testing<br>Revision Knee Femur Augment Testing<br>Apex PS Revision 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 Revision Knee Wear Review ISO 14243-3- Implants for surgery -- Wear of total knee-joint prostheses -- |

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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 .

All samples tested met the acceptance criteria. No clinical studies were performed.

Clinical Test Summary Conclusions

The Apex Revision Knee System is substantially equivalent to the predicate devices.

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

FEB 2 9 2012

OMNIlife science. Inc. % Ms. Christine Nassif Director, Regulatory Affairs 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718

Received: February 15, 2012

Re: K112891

Trade/Device Name: Apex Revision 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: February 13, 2012

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.

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Page 2 - Ms. Christine Nassif

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); 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,

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:

Device Name: Apex Revision 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 or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.

The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur.

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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI 2891 510(k) Number_