SYMMETRIC TOTAL KNEE SYSTEM

{0}------------------------------------------------ K080199 # '1/0 #### Section 5: - 1. Submitted by: Submitter's Name Address: Establishment Registration#: Correspondent: Date: # 2. Device Name: Trade Name: Proprietary Name: Common Name: Classification Name: ### 3. Device Class Regulatory Class: Product Code: Panel: Regulation Number: #### 4. Predicate Device: # 510(k) Summary 21 CFR 807.92 Signal Medical Corporation 1000 Des Peres Road, Suite 140 St. Louis, MO 63131 P: 314-775-0518 F: 314-775-0524 1932213 Brian Katerberg; Leo Whiteside, MD; Louis Serafin, MD March 4, 2011 SymmetricTM Total Knee System Signal Medical Corp. Symmetric™ Total Knee System Knee Prosthesis - Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, metal/polymer (888.3560 - JWH) Class II JWH Orthopedic 21 CFR 888.3560 Beacon Cemented and Uncemented Total Knee System (K051510), Profix Total Knee System (K933958) Similarities to these components are based on design, indications for use, and materials. JUL 3 2008 {1}------------------------------------------------ | | Category | Symmetric Total<br>Knee System | Beacon Cemented<br>and Uncemented<br>Total Knee System | Profix Total Knee<br>System | |--------------------------|--------------------|--------------------------------|--------------------------------------------------------|-----------------------------| | | 510K # | K080199 | K051510 | K933958 | | | Fixation Method | Cemented | Cemented/less | Cemented | | Femoral | Width (mm) | 50-86mm | 58-82mm | Similar | | | Substrate Material | CoCr | CoCr | CoCr | | | Coating | Ti Plasma Spray | Sintered Beads | Sintered Beads | | Tibial<br>Tray | ML-Width | 49-84mm | 63-88mm | Similar | | | Substrate Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | | | Coating | Ti Plasma Spray | Sintered Beads | Sintered Beads | | Tibial<br>Poly | Thickness w/ tray | 10-35mm | 10-20mm | Similar | | | Standard/Deep | Standard/Deep | Standard/Deep | Standard/Deep | | | Material | UHMWPE | UHMWPE | UHMWPE | | Metap-<br>hyseal<br>Stem | Diameters | 18-24mm | NA | Similar | | | Lengths | 50-63mm | NA | Similar | | | Attachment Method | Morse Taper | NA | Morse Taper | | | Material | Titanium 6Al-4V | NA | Titanium 6Al-4V | | Revision<br>Stem | Diameters | 10-26mm | NA | Similar | | | Lengths | 100 - 200mm | NA | Similar | | | Fixation Method | Morse Taper | NA | Morse Taper | | | Material | Titanium 6Al-4V | NA | Titanium 6Al-4V | | Patella | Disk Diameter | 25 - 40mm | 26 - 41mm | Similar | | | Material | UHMWPE | UHMWPE | UHMWPE | | | Intended Use | Cemented | Cemented | Cemented | # Predicate Device Comparison {2}------------------------------------------------ K080199 # 3/4 #### 5. Device Description: The Symmetric™ Total Knee System is intended for the resurfacing of the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem) and a polyethylene tibial insert and patellar component. The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo). The femoral component will be available in eight sizes (1-8) and will have a central post (with a 5° valgus angle) and gussets to aid in rotational stability and to increase strength. It will be plasma sprayed with Commercially Pure Titanium (CPTi). The TIBIAL TRAY is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti 6Al-4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside broviding rotational stabilization and increased tray strength. Four screw holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 8 sizes (1-8) and is plasma sprayed with Commercially Pure Titanium (CPTi). The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semiconstrained and is captured in the tibial tray by the mating capture features. The insert is available in nine thicknesses (10, 12, 14, 16, 18, 20, 25, 30, 35mm) and 8 sizes (1-8). The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system. The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component. The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component. #### 6. Device Intended Use: The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications. - 1. Osteoarthritis (for cemented use only) - 2. Rheumatoid Arthritis (for cemented use only) - 3. Traumatic Arthritis (for cemented use only) - 4. Where the use of a more conservative procedure has failed or is unacceptable. ## 7. Performance Summary: #### Non-Clinical Testing: -Testing performed was consistent with Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented {3}------------------------------------------------ K08A99 #4/4 Prostheses; Guidance for Industry and FDA (dated January 16, 2003). Tests included poly push in, push off, and pull out; tibial tray and femoral fatigue; femoral-tibial and femoralpatellar joint stability; femoral-tibial and femoral-patellar contact area/contact stress; static tensile and torsional testing of the modular stem/trunnion junction; and fatigue testing of the modular stems in conjunction with both the femur and tibia. ## Clinical Testing: No clinical data was utilized for the basis of substantial equivalence. #### Conclusions: Based on the Symmetric Total Knee System having the same intended use, the results of the non-clinical tests being substantially equivalent to or better than those of at least one predicate device, and the indications for use being similar, we feel that there are no new questions of safety or effectiveness. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming the body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAR 1 1 2011 Signal Medical Corporation % Mr. Brian Katerberg Engineer 1000 Des Peres Road, Suite 140 Saint Louis, Missouri 63131 Re: K080199 Trade/Device Name: Symmetric Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 01, 2008 Received: July 03, 2008 Dear Mr. Katerberg: This letter corrects our substantially equivalent letter of July 03, 2008. 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 (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. 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 {5}------------------------------------------------ Page 2 - Mr. Brian Katerberg 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Aling B. Rh fur Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Section 4: # Indications for Use 510K Number: K080199 Device Name: SymmetricTM Total Knee Augments Indications For Use: The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications. - 1. Osteoarthritis (for cemented use only) - 2. Rheumatoid Arthritis (for cemented use only) - Traumatic Arthritis (for cemented use only) 3. - 4. Where the use of a more conservative procedure has failed or is unacceptable. 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) for M. Melkeson (a. Oft) (Div/sion Sign-Oft) (Division Sign-On) Surgical, Orthopedic, Division of Surgical, Orthopedic, Division of Surgion , and Restorative Devices Number K080199 510(k) Number K080199