SYMMETRIC TOTAL KNEE AGUMENTS

{0}------------------------------------------------ # SIGNAL MEDICAL CORPORATION Image /page/0/Picture/1 description: The image shows a series of maritime signal flags, each corresponding to a letter of the alphabet. Below each flag is the corresponding letter, spelling out the word "ORTHOPAEDICS". The flags are arranged in a horizontal row, with each flag enclosed in a square frame. The letters are printed in a simple, sans-serif font. 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 Symmetric™ Total Knee Augments Signal Medical Corp. Symmetric™ Total Knee Augments Knee Prosthesis - Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, metal/polymer (888.3560 - JWH) Class II JWH Orthopedic 21 CFR 888.3560 SymmetricTM Total Knee System (K080199), Revision Knee System (K043440), Regenerex Ultra Porous Construct - Titanium Knee Augments (K053505), Regenerex Porous Titanium Sleeve Augments (K072336), Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments (K053340), Genesis II Total Knee System (K953274) Similarities to these components are based on design, indications for use, and materials. MAR - 7 2011 {1}------------------------------------------------ | Category | Symmetric Total<br>Knee Augments | Symmetric Total<br>Knee System | Smith & Nephew<br>Revision Knee<br>System | Regenerex™ Ultra<br>Porous Construct -<br>Titanium Knee<br>Augments | Regenerex™<br>Porous Titanium<br>Sleeve Augments | Trabecular Metal™<br>Tibial and Femoral<br>Cone Augments | Genesis II Total<br>Knee System | | |----------------|----------------------------------|-------------------------------------|-------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|---------------------------------------------------|----| | 510K # | K100370 | K080199 | K043440 | K053505 | K072336 | K053340 | K953274 | | | Intended Use | Cemented | Cemented | Cemented | Cemented/less | Cemented/less | Cemented/less | Cemented | | | Femoral wedges | Thickness | 5-10mm posterior,<br>5-15mm distal | NA | Similar | Similar | NA | NA | NA | | | Fixation Method | Cemented to implant | NA | Cemented to implant | Cemented or screwed<br>to implant | Cemented or screwed<br>to implant | NA | NA | | | Material | Titanium 6Al-4V | NA | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | NA | NA | | | Coating | Titanium Plasma<br>Spray ASTM F1580 | NA | NA | Regenerex™<br>Titanium Porous<br>Coating ASTM F1580 | Regenerex™<br>Titanium Porous<br>Coating ASTM F1580 | NA | NA | | Femoral wedges | Thickness | 5-10mm posterior,<br>5-15mm distal | NA | Similar | Similar | NA | NA | NA | | | Fixation Method | Cemented to implant | NA | Cemented to implant | Cemented or screwed<br>to implant | Cemented or screwed<br>to implant | NA | NA | | | Material | Titanium 6Al-4V | NA | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | NA | NA | | | Coating | Titanium Plasma<br>Spray ASTM F1580 | NA | NA | Regenerex™<br>Titanium Porous<br>Coating ASTM F1580 | Regenerex™<br>Titanium Porous<br>Coating ASTM F1580 | NA | NA | | Femoral Cone | ML Width | 47-77mm | NA | NA | NA | NA | Similar | NA | | | Height | 28-46mm | NA | NA | NA | NA | Similar | NA | | | Fixation Method | Cemented onto<br>femoral component | NA | NA | NA | NA | Cemented onto<br>femoral component<br>Regenerex™ | NA | | | Material | Titanium 6Al-4V | NA | NA | NA | NA | Tantalum Trabecular<br>Metal™ | NA | | | Coating | Titanium Plasma<br>Spray ASTM F1580 | NA | NA | NA | NA | Regenerex™<br>Titanium Plasma<br>Spray ASTM F1580 | NA | | Tibial Cone | ML Width | 45-70mm | NA | NA | NA | NA | Similar | NA | | | Height | 18-30mm | NA | NA | NA | NA | Similar | NA | | | Fixation Method | Cemented onto tibial<br>component | NA | NA | NA | NA | Cemented onto tibial<br>component<br>Regenerex™ | NA | | | Material | Titanium 6Al-4V | NA | NA | NA | NA | Tantalum Trabecular<br>Metal™ | NA | | | Coating | Titanium Plasma<br>Spray ASTM F1580 | NA | NA | NA | NA | Regenerex™<br>Titanium Plasma<br>Spray ASTM F1580 | NA | | Trunnion | Offset Distance | 4mm | NA | NA | NA | NA | NA | NA | | | Extension Length | 50mm | NA | NA | NA | NA | NA | NA | | | Fixation Method | Morse Taper | NA | NA | NA | NA | NA | NA | | | Material | Titanium 6Al-4V | NA | NA | NA | NA | NA | NA | | | Length | 100, 150, 200mm | NA | NA | NA | NA | NA | NA | | Stems | Diameter | 10 through 26mm | NA | NA | NA | NA | Similar | NA | | | Fixation Method | Morse Taper | NA | NA | NA | NA | Similar | NA | | | Material | Titanium 6Al-4V | NA | NA | NA | NA | Morse Taper<br>Titanium 6Al-4V | NA | Sec 5: Page 2 of 4 3/4/11 K100370 K100370 #²/₄ {2}------------------------------------------------ ## 5. Device Description: The Symmetric™ Total Knee Augments are intended to complement the Symmetric Total Knee System. The system consists of metallic wedges, stems, cones, sleeves, and offset trunnions that can be used with the Symmetric Total Knee System to provide increased bone contact and support during total knee arthroplasty when more conservative methods have failed. The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee. The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays. The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone. The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively. The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation. The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss. {3}------------------------------------------------ KVO0320 *Mly # 6. Device Intended Use: The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications. - 1. Osteoarthritis - 2. Rheumatoid Arthritis - 3. Traumatic Arthritis or correction of posttraumatic joint deformity - Where the use of a more conservative procedure has failed or is unacceptable. 4. All components are for cemented use. Additional indications for use: - Whenever a cone is used, a revision stem is to be used as well. . # Material Characteristics: | COMPONENT | CLEARED DEVICE | NEW DEVICE | |----------------------------|----------------|------------| | Femoral Wedges | ASTM F1472 | ASTM F1472 | | Tibial Wedges | ASTM F1472 | ASTM F1472 | | Femoral and Tibial Cones | ASTM F1472 | ASTM F1472 | | Offset Trunnion | ASTM F1472 | ASTM F1472 | | (Partially) Coated Stems | ASTM F1472 | ASTM F1472 | | Rectangular Revision Stems | ASTM F1472 | ASTM F1472 | | Plasma Spray Coating | ASTM F1580 | ASTM F1580 | # 7. Performance Summary: # Non-Clinical Testing: A writeup of the testing completed for this 510(k) is included in Section 18. Testing included compressive fatigue and static testing, torsional testing, and assembly/disassembly testing of the offset trunnion with a tray and stem. # 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Signal Medical Corporation % Mr. Brian Katerberg Engineer 1000 Des Peres Road, Suite 140 Saint Louis, Missouri 63131 MAR - 7 2011 Re: K100370 Trade/Device Name: 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 Dated: February 25, 2011 Received: March 2, 2011 Dear Mr. Katerberg: 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 r reade or actived 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 or uny I vithe Act's requirements, including, but not limited to: registration and listing (21 {5}------------------------------------------------ Page 2 - Mr. Brian Katerberg 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/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, AZ. B. R.L. fer 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: K100370 # Device Name: SymmetricTM Total Knee Augments #### Indications For Use: The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications. - 1. Osteoarthritis - 2. Rheumatoid Arthritis - 3. Traumatic Arthritis or correction of posttraumatic joint deformity - 4. Where the use of a more conservative procedure has failed or is unacceptable. All components are for cemented use. Additional indications for use: - Whenever a cone is used, a revision stem is to be used as well. . 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 melkerson (Division Sign-Off) (Division Sign-of Surgical, Orthopedic, Division of Restorative Devices K100370 510(k) Number