APEX PS KNEE SYSTEM

{0}------------------------------------------------ # '14 MAR 2 5 2011 # 510(k) Summary # K102578 - Apex PS Knee ™ System # 24 March, 2010 | Submitter | OMNIlife science, Inc.<br>50 O'Connell Way<br>E. Taunton MA 02718 | Contact | Radhika Pondicherry<br>Regulatory Affairs<br>774-226-1852<br>(508) 822-6030 (fax) | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------------------------------------------------------------| | Preparation Date | 24 March, 2010 | | | | Device Name<br>Trade Name<br>Common/Classification<br>Name | Apex PS Knee™ System<br>Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented<br>prosthesis<br>Knee joint patellofemorotibial metal/polymer porous-coated uncemented<br>prosthesis. | | | | Regulatory Class<br>Product Code | Class II per 21 CFR §888.3560, §888.3565<br>JWH, MBH | | | | Legally Marketed<br>Predicate Device(s) | • K060192- Apex Knee™ System- cleared 15Jul2006<br>• K073602- Apex Knee™ System Porous Coated Femoral<br>Components(cementless), cleared 14Feb2008<br>• K950010- Darwin Knee System, cleared 15May1995<br>• K936159- The Natural-Knee® II knee system, cleared 22May2005 | | | | Device Description | The APEX PS Knee System includes a posterior stabilized Femur Component<br>incorporating a proportionally sized box. The Femur Component has the same<br>bone cuts as the Apex Knee™ System (K060192) with the addition of a cut for the<br>Femur Component box. Femur Components will be available in both cemented<br>and uncemented versions. Size ranges, high flex, and all other design features of<br>the Apex Knee System are retained. The PS Insert has a medio-lateral constraint<br>and utilizes the Apex Knee System Tibial Baseplate. For each PS Insert, a range of<br>UHMWPE thicknesses are available to aid in obtaining the proper soft tissue<br>balance across the knee joint. | | | | Indications for Use | The Apex Knee™ System is intended for use as a primary or revision total knee<br>replacement. This prosthesis may be used for the following conditions, as<br>appropriate:<br>• Non-inflammatory degenerative joint disease, including osteoarthritis and<br>avascular necrosis;<br>• Rheumatoid arthritis;<br>• Correction of functional deformity;<br>• Revision procedures where other treatments or devices have failed;<br><br>The porous coated femoral component may be used cemented or uncemented<br>(biological fixation). All other femoral, tibial baseplate and patellar components<br>are indicated for cemented use only.<br>The Apex Knee™ Modular Tibia System Tibial Augment are intended to be bolted<br>to the Tibia baseplate and cemented to the prepared tibia. | | | {1}------------------------------------------------ K102578 #2/4 ## Predicate Device Comparison | | | Device Comparison | | | | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | APEX PS TKA<br>(Subject<br>Device) | APEX CR TKA<br>(K060192,<br>K073602) | Darwin Knee<br>System<br>(K950010) | Natural Knee II<br>(K936159) | | | Body Site | Knee | Knee | Knee | Knee | | | Intended use | Primary and<br>revision 3<br>compartment<br>TKA.<br>Is intended for<br>use as a<br>primary or<br>revision total<br>knee<br>replacement. | Primary and<br>revision 3<br>compartment<br>TKA.<br>Is intended for<br>use as a primary<br>or revision total<br>knee<br>replacement. | Primary and<br>revision 3<br>compartment<br>TKA.<br>Provides<br>seamless<br>transitions<br>between<br>primary and<br>the most<br>difficult<br>revision cases. | Primary and<br>revision 3<br>compartment<br>TKA. | | | Patient<br>Population | Skeletally<br>mature<br>patients. | Skeletally<br>mature patients. | Skeletally<br>mature<br>patients. | Skeletally<br>mature<br>patients. | | | Similar Design and Specifications | | | | | | | Femur<br>Component | Femur<br>Component:<br>Identical to<br>K060192-<br>noncoated and<br>K073602-<br>coated | Femur<br>Component:<br>Coated and<br>noncoated | Surface<br>preparation<br>for use with<br>cement. | Femoral<br>Component:<br>CSTi™ titanium<br>on CoCr porous<br>coating | | | Tibial<br>Baseplate/<br>Component | Tibial<br>Component:<br>Identical to<br>K060192 -non<br>coated | Tibial<br>Component:<br>Non-coated | | Tibial<br>Component:<br>Titanium alloy | | | Asymmetric<br>femur,<br>anatomic<br>patellar<br>groove | Yes<br>Designed with a<br>deep, wide<br>patellar groove | Identical<br>Designed with a<br>deep, wide<br>patellar groove | Similar<br>Deep single<br>radius<br>Trochlear<br>groove,<br>enables the<br>patella to sit<br>deeply in the<br>groove even at<br>high flexion<br>angles. | Similar<br>Deepened<br>trochlear<br>groove<br>prevents<br>excessive load<br>on<br>the patellar<br>component<br>while<br>providing<br>excellent range<br>of motion. | | | Anatomic<br>asymmetric<br>tibial baseplate | Monobloc: Yes<br>Modular: No | Monobloc: Yes<br>Modular: No | No | Yes | | | | | | | | | | Condylar Box<br>(cam) and<br>Tibial Post<br>(spine) | Rounded, open,<br>and sloped box<br>- Minimizes<br>tibial spine<br>edge loading<br>and potential<br>for<br>polyethylene<br>wear or tibial<br>spine fracture. | Not Applicable,<br>CR device | Squared box<br>(cam) | Squared box<br>(cam) | | | PS Insert | PS style insert<br>with cam and<br>post to control<br>kinematics | N/A | PS style insert<br>with cam and<br>post to control<br>kinematics | PS style insert<br>with cam and<br>post to control<br>kinematics | | | PS Insert Post | Yes | No | Yes | Yes | | | High Flexion<br>Design Option | Full flexion to<br>140° | Full flexion to<br>140° | Similar | Similar | | {2}------------------------------------------------ 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 {3}------------------------------------------------ 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. | {4}------------------------------------------------ # 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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