HLS KNEETEC SYSTEM

{0}------------------------------------------------ <094013 #1 MAY - 5 2011 ### Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - HLS KNEETEC System Implants Chirur Date prepared: May 5th, 2011 Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92 ### 1) Device name | Trade name: | HLS KNEETEC System | |----------------------|--------------------------------------------------------------------------------------------------------| | Common name: | Total anatomical knee prosthesis | | Classification name: | 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis. | ### 2) Submitter Tornier Rue Doyen Gosse 38330 Saint Ismier - France ### 3) Company contact Tornier Mrs Séverine Bonneton Regulatory affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail: severine.bonneton@tornier.fr ### 4) Classification | Device class: | Class II | |-----------------------|------------| | Classification panel: | Orthopedic | | Product code: | 87 JWH | 5) Equivalent / Predicate device HLS Noetos System, Tornier, K013906 PFC Modular Plus Offset Tibial Tray, DePuy, Inc., K984158 NexGen Complete Knee Solution Legacy Posterior Stabilized, Zimmer, K991581 AGC Total Knee System, Biomet, Inc., K833021, K912245, K984054 Image /page/0/Picture/15 description: The image shows a logo with the letters 'TP' inside a hexagon. The letter 'T' is above the letter 'P', and they are both stylized with thick lines. The hexagon is outlined in black, and the letters are also in black. The logo appears to be a simple, geometric design. TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 1/ page 5 S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B SIEGE SOCIAL: rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE {1}------------------------------------------------ K094013#2/5 # Implants Chirurgicau ### 6) Device description The HLS Kneetec prosthesis is intended for use as a semi-constrained replacement system. The HLS Kneetec cemented prosthesis with fixed tibial insert consists of three components intended to be used with bone cement: the femoral implant, the tibial implant and the patella. The tibial implant consists of two components: tibial insert and tibial tray, the tibial insert is clipsed on the tibial tray can be extended by a stem. The patella of the joint may be preserved or resurfaced with the patellar implant shared by all ranges of the HLS Kneetec prostheses. The present device modification submission consists of the addition of a new prosthesis named HLS Kneetec to the HLS Knee range. The HLS Kneetec prosthesis is an evolution of the HLS Noetos System, CE marked in Europe since 1996 and cleared in the USA since 2001 (K013906). The HLS Kneetec prosthesis keeps HLS Noetos benefits and improves the compliance with patient's anatomy, with a new design to provide better bone coverage and greater interchangeability between sizes. The HLS Kneetec System completes the Tornier HLS range of knee implants. ### 7) Materials Femoral and tibial implants are manufactured from chromium cobalt alloy according to ISO 5832-4. The tibial plug is made of chromium cobalt alloy (CoCr) according to ISO standard 5832-7 or ISO standard 5832-12. Tibial inserts and the patella are made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. ### 8) Indications for use This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. It is also intended for the revision of knee prostheses. The HLS Kneetec is intended for cemented use only. Image /page/1/Picture/10 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is designed with a thick vertical line and a horizontal bar at the top, and there is a small triangle above the horizontal bar. The hexagon is outlined with a dashed line, giving the logo a geometric and somewhat technical appearance. TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 21 page 5 S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B SIEGE SOCIAL : rue du Doven Gosse - 38330 SAINT-ISMIER - FRANCE {2}------------------------------------------------ ### 9) Summary of technological characteristics | Main features or system<br>characteristics | | HLS Kneetec<br>System | HLS Noetos<br>System | PFC Modular<br>Plus Offset<br>Tibial Tray | NexGen<br>Complete Knee<br>solution Legacy<br>Posterior<br>Stabilized | AGC<br>Total<br>Knee System | |--------------------------------------------|---------------|---------------------------|---------------------------|-------------------------------------------|-----------------------------------------------------------------------|-----------------------------------| | | | | | | | | | Materials | Femoral part | CoCr alloy | CoCr alloy | CoCr alloy | CoCr alloy | CoCr alloy<br>+<br>Titanium alloy | | | Tibial insert | UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | | | Tibial tray | CoCr alloy | CoCr alloy | Titanium alloy | Titanium alloy | CoCr alloy<br>+<br>Titanium alloy | | | Patella | UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | | Postero stabilized | | yes | yes | yes | yes | yes | | Sizes | Femoral part | 9 Right<br>9 Left | 6 Right<br>6 Left | 6 Right<br>6 Left | 7 Right<br>7 Left | 6 Right<br>6 Left | | | Tibial insert | 6 sizes<br>6 thicknesses | 6 sizes<br>6 thicknesses | 6 sizes<br>8 thicknesses | 8 sizes<br>6 thicknesses | 8 sizes<br>6 thicknesses | | | Tibial tray | 7 sizes | 6 sizes | 6 sizes | 8 sizes | 8 sizes | | | Patella | 4 diameters | 3 diameters | 4 diameters | 5 diameters | 3 diameters | | Method of fixation | | Cemented | Cemented | Cemented | Cemented | Cemented<br>(interlok) | | Indications for use | | Total knee<br>replacement | Total knee<br>replacement | Total knee<br>replacement | Total knee<br>replacement | Total knee<br>replacement | | Terminal sterilization | | Gamma | Gamma | Gamma | Gamma | Gamma | | Manufacturer | | TORNIER | TORNIER | DePuy | Zimmer | Biomet | | K-number | | K094013 | K013906 | K984158 | K991581 | K984054<br>K912245<br>K833021 | The indications for use, the technical characteristics (manufacturing principle, method of fixation), the packaging and the sterilization process of the new HLS Kneetec System are similar or identical to the predicate devices. The different technical characteristics of the new HLS Kneetec System compared to the predicate devices are a new design of the tibial tray, a new femoral trochlear groove design with a new patella dome design. The new design of the HLS Kneetec System compared to the predicate HLS Noetos (K0143906) provides a better bone coverage and a greater interchangeability between sizes. Image /page/2/Picture/5 description: The image shows a logo inside of a hexagon. The logo appears to be a stylized letter "T" with a horizontal bar above it. The letter "T" is symmetrical and has a thick vertical line with two curved shapes on either side. TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 3/ page 5 S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE {3}------------------------------------------------ K094013*4/5 ### 10) Non-clinical testing Non-clinical testing was not necessary to determinate substantial equivalence between the new HLS Kneetec System and the cited predicate devices about: - The indications for use of the new HLS Kneetec System are identical to the indications for use of the predicate HLS Noetos System (K013906) and are very similar with the other predicates the PFC Modular Plus Offset Tibial Tray (K984158), the NexGen Complete Knee solution Legacy Posterior Stabilized (K991581) and the AGC Total Knee System (K833021, K912245, K984054). - . The intended use of the new HLS Kneetec System are identical to the intended use of predicates HLS Noetos System (K013906), PFC Modular Plus Offset Tibial Tray (K984158), NexGen Complete Knee solution Legacy Posterior Stabilized (K991581) and AGC Total Knee System (K833021, K912245, K984054). - -The raw materials of the new components of the HLS Kneetec System are identical to the raw materials of predicate HLS Noetos System (K013906). - -The fixation method of the new components of the HLS Kneetec is identical to the fixation method of the predicate components of the HLS Noetos (K013906), the PFC Modular Plus Offset Tibial Tray (K984158), the NexGen Complete Knee solution Legacy Posterior Stabilized (K991581) and the AGC Total Knee System (K833021, K912245, K984054).1379, and K091751). Non clinical testing was necessary to determinate substantial equivalence between the new HLS Kneetec System and the cited predicate devices about: - -The new design of the femoral component: A contact area stress / pressure test was performed to compare contact pressure on UHMWPE tibial insert between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906- Equivalent size) at each flexion angle. The acceptance criteria is: the contact area stress and the contact pressure between the new HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906- Equivalent size) must be equivalent. Results of verification: there is no significant difference between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906), the contact area stress /pressure is equivalent between the two prostheses. So, the HLS Kneetec size 2 and the cleared HLS Noetos size 1(K013906) are equivalent. Constraint test was performed to determine the constraint forces in anterior-posterior displacement, medial-lateral displacement and internal-external rotation between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906 - Equivalent size) according to ASTM F1223. The acceptance criteria is: load displacement curves must be equivalent to the predicate device HLS Noetos (K013906). Results of verification: there is no significant difference between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906), the frame of load displacement curves is equivalent between the two prostheses. So, the HLS Kneetec size 2 and the cleared HLS Noetos size 1(K013906) are equivalent. Image /page/3/Picture/18 description: The image shows a logo with a stylized tree inside of a hexagon. The tree has a thick trunk and a wide, flat top. The logo is black and white and appears to be a simple line drawing. The hexagon provides a border around the tree symbol. TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 4/ page 5 S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE {4}------------------------------------------------ K094013 # 5/5 ### The new tibial tray design: A fatigue test on the fixed Kneetec tibial tray was done to validate the fixed tibial tray of the HLS Kneetec following existing standards (Fatigue tests: ASTM F1800:2007 & NF ISO 14879-1:2000). The acceptance criteria is: the fixed tibial tray tested must resist to 10 millions of cycles without any damages. Results of verification: five fixed tibial trays have been tested during 10 millions of cycles under maximum load of 237daN. No damage nor ruptures have been noted on the five fixed tibial trays. So, the new tibial tray of the HLS Kneetec is conformed to the standards. - -The new femoral trochlear groove design with a new patella dome design: A comparative study was done to verify that the new design of the trochlea has equivalent congruence with the new patella. We have conducted a comparative test versus the marketed predicate device HLS Noetos size 1(K013906) on the worst case component HLS Kneetec size 2 (equivalent size) to study the tracking of the patella under quadriceps motion. The acceptance criteria is: the contact area and trajectories must be equivalent to the predicate device HLS Noetos (K013906). Results of verification: for the HLS Kneetec and the predicate HLS Noetos (K013906) the principle is the same, the tracking of the patella is steady when moving the quadriceps in each position. So, the design of the patella and the patella groove between the new HLS Kneetec and the cleared HLS Noetos (K013906) are equivalent. Results of engineering studies referenced in this 510(k) submission demonstrate the proposed HLS Kneetec System device is substantially equivalent to the predicate devices. ### 11) Substantial equivalence conclusion Based upon this comparative study, substantial equivalence of the new HLS Kneetec System to the already cleared components of the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process: - The components of the HLS Kneetec System are compared to the predicate devices. । - The components of the HLS Kneetec System have the same intended use as the HLS Noetos System, the PFC Modular Plus Offset Tibial Tray, the NexGen Complete Knee solution Legacy Posterior Stabilized and the AGC Total Knee System and very similar indications for use. - Major technological characteristics are equivalent between the HLS Kneetec System and the predicate । devices: - ﮯ Equivalence of general features - -Equivalent polyethylene thickness - -Equivalent materials - -Equivalent means of fixation - -Equivalent prosthetic dimensions Therefore, in light of the above information, the company believes that the components of the HLS Knetter System may be cleared via the 510(k) notification process for use as a total knee prosthesis. Image /page/4/Picture/22 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The logo has a slightly distressed or textured look, suggesting it may be from a vintage or worn design. The overall impression is simple, clean, and potentially representative of a brand or organization with a name starting with 'T'. TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 3/ page 5 S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three human figures in the negative space of the eagle's body. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Tornier % Ms. Severine Bonneton Regulatory Affairs Specialist l 61, rue Lavoisier - Montbonnot 38334 Saint-Ismier Cedex - France Re: K094013 MAY - 5 20:1 Trade/Device Name: HLS KNEETEC System Regulation Number: 21 CFR 88.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: April 26, 2011 Received: April 29, 2011 Dear Ms. Bonneton: 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 indictions 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 of ections 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 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 {6}------------------------------------------------ Page 2 - Mrs. Severine Bonneton 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 100-1050. lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0fffices/ucm115809.html 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Aty B. R.h Mark N. Melkerson Director-Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K094013 Device Name: HLS KNEETEC System Indications For Use: This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also intended for the revision of knee prostheses. The HLS Kneetec is intended for cemented use only. 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. pellerm (Division/Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices Page 1 of 1 510(k) Number K094013 Section 4 Tornier