EMPOWR Porous Knee System

{0}------------------------------------------------ October 4, 2017 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text. Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758 Re: K171991 Trade/Device Name: EMPOWR Porous Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: June 30, 2017 Received: July 3, 2017 Dear Teffany Hutto: 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). 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Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171991 Device Name EMPOWR Porous Knee System Indications for Use (Describe) Joint replacement is indicated for patients suffering from disability due to: · degenerative, post-traumatic or rheumatoid arthritis; · avascular necrosis of the femoral condyle; · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; · moderate valgus, varus or flexion deformities; · treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ Porous Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR 3DKNEE™ Porous Tibia which are intended for cementless applications. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------| | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Date: September 29, 2017 Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758 Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com | Product | Common Name | Classification | Product Code | |---------------------------|--------------------|----------------|--------------| | EMPOWR Porous Knee System | Total Knee Implant | Class II | MBH | | Product Code | Regulation and Classification Name | |--------------|------------------------------------------------------------------------------------------------------| | MBH | 21 CFR 888.3565, Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated<br>Uncemented Prosthesis | ### Description: The EMPOWR POROUS KNEE System is a line extension to the EMPOWR Knee platform (cleared via K143242), to include porous coated femoral and tibial baseplate implants and instruments, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences. The EMPOWR 3DKNEE Porous Femur has porous coating applied inside of the cement pocket. The added porous coating allows for long term biological fixation of the device. Therefore, this device is indicated for cementless use. The EMPOWR Porous Tibia also have a porous coating applied to the backside of the baseplate to allow for long term biological fixation of the device. The distal geometry includes 4 peripheral pegs for initial fixation along with a fully webbed keel to provide rotational stability and initial fixation. ### Indications for Use: Joint replacement is indicated for patients suffering from disability due to: - degenerative, post-traumatic or rheumatoid arthritis; ● - avascular necrosis of the femoral condyle; ● - post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, ● dysfunction or prior patellectomy; - moderate valgus, varus or flexion deformities; - treatment of fractures that are unmanageable using other techniques. ● This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ Porous Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR 3DKNEETM Porous Tibia which are intended for cementless applications. {4}------------------------------------------------ ### Predicate Devices: - Empowr Knee System (K143242) . - 3DKnee Porous Femur (K032905) ● - . FMPTM Porous Coated Acetabular Shells (K072888) ## Comparable Features to Predicate Device(s): The EMPOWR POROUS KNEE line extension includes a modified version of the EMPOWR 3DKNEE™ Non-porous Femoral Implants. The material, articulating geometry, and articulating surface roughness are identical to the EMPOWR 3DKNEE™ Non-porous Femoral Implants. The EMPOWR POROUS KNEE line extension also includes a modified version of the EMPOWR non-porous Tibial Baseplate Implants. The sizing architecture and proximal geometry remains identical to EMPOWR Non-porous Tibial Baseplate Implants. ### Key Differences in Subject Device to Predicate: The only modification made to the EMPOWR POROUS KNEE implants compared to the EMPOWR 3DKNEE non-porous Femoral Implants is the addition of porous coating inside of the cement pocket. The porous coating material and process is identical to the porous coating applied to an existing DJO femoral component, 3D Knee Porous Femur (K032905). The added porous coating allows for long term biological fixation of the device. Therefore, this device is indicated for cementless use. The distal side of the EMPOWR Porous Tibia was modified to accommodate a cementless indication. The distal geometry includes 4 peripheral pegs for initial fixation along with a fully webbed keel to provide rotational stability and initial fixation. The backside of the baseplate is also coated with porous coating to allow for long term biological fixation of the device. This porous coating is identical to coating applied to existing FMP™ Porous Coated Acetabular Shells (K072888). Non-Clinical Testing: Mechanical testing (femur fatigue testing, baseplate fatigue testing) has demonstrated the device's ability to perform under expected conditions. All testing has determined that the device is substantially equivalent to the predicate devices. Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing. Clinical Testing: Clinical testing was not required Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.