← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K072858 # TC-PLUS PRIMARY KNEE SYSTEM (K072858) _Smith & Nephew, Inc. · JWH · Nov 20, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K072858 ## Device Facts - **Applicant:** Smith & Nephew, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Nov 20, 2007 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The TC-PLUS Primary Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasy. It is indicated for degenerative, post traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery. ## Device Story The TC-PLUS Primary Knee System is a tricompartmental total knee prosthesis consisting of femoral, patellar, and tibial components with an ultra-high molecular weight polyethylene (UHMWPE) articular insert. Designed for cemented implantation, the system replaces damaged knee joint surfaces to restore function and alleviate pain. Components are available with or without plasma-sprayed titanium coating for bone fixation. The system integrates existing components from the VKS Knee System and TC-PLUS Solution Knee System, with the addition of a size 12 tibial baseplate and 20mm thick articular inserts. It is intended for use by orthopedic surgeons in a hospital or surgical center setting. The device provides a mechanical solution for joint reconstruction, with clinical benefit derived from restoring joint stability and mobility in patients with severe arthritis or deformity. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to previously cleared predicate devices. ## Technological Characteristics Tricompartmental total knee prosthesis; materials include metal components (with optional plasma-sprayed titanium coating) and ultra-high molecular weight polyethylene (UHMWPE) articular inserts. Semi-constrained, cemented design. System includes femoral, patellar, and tibial baseplate components. No electronic or software components. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - TC-PLUS Solution Knee ([K000666](/device/K000666.md)) - TC-PLUS Porous Femoral Components ([K011258](/device/K011258.md)) - VKS Knee System ([K022204](/device/K022204.md)) ## Reference Devices - Cancellous bone screws ([K011719](/device/K011719.md)) - Cancellous bone screws ([K994146](/device/K994146.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## Smith & Nephew, Inc. Summary of Safety and Effectiveness TC-Plus Primary Knee System Contact Person and Address Date of Summary: 09/28/2007 Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054 NOV 2 0 2007 Name of Device: Smith & Nephew TC-Plus Primary Knee System Common Name: TC-Plus Primary Knee System #### Device Description Subject of this premarket notification is the TC-PLUS Primary Knee System. The TC-PLUS Primary Knee System is a tricompartmental total knee prosthesis comprised of femoral, patellar, and tibial components with an ultra-high molecular weight polyethylene articular insert. The femoral and tibial baseplate components are offered with or without a plasma-sprayed titanium coating. The TC-PLUS Primary Knee System is comprised of existing implant components of the previously-cleared VKS Knee System and the TC-PLUS Solution Knee System. The femoral components are the previouslycleared TC-PLUS Solution femoral components available with (K011258) or without (K000666) a titanium plasma-spray coating. The articular insert and tibial baseplate components in the TC-PLUS Primary Knee System are identical to those of the VKS Knee System (K022204). The titanium plasma-sprayed tibial baseplates in the system feature holes to accept cancellous bone screws' for supplemental fixation. The patellar components of the subject knee system are the existing patellar implants cleared as part of K000666. There are no new implant designs included in this premarket notification other than the addition of a size 12 tibial baseplate and size 20mm thick articular inserts. This 510(k) seeks to combine two existing knee systems into one and to also harmonize the sizing for both systems. #### Device Classification 21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis - Class II #### Indications for Use The TC-Plus Primary Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasy. It is indicated for degenerative, post traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier 1 The cancellous bone screws used with the TC-PLUS Primary Knee System are existing bone screws cleared as part of 510(k) K011719 and K994146. {1}------------------------------------------------ patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery. #### Substantial Equivalence Information The overall design of the Smith & Nephew TC-Plus Primary Knee System is substantially equivalent to previously cleared devices listed below: | MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE | |---------------------|-----------------------------------|---------|----------------| | PLUS Orthopedics AG | TC-PLUS Solution Knee | K000666 | 10/13/00 | | PLUS Orthopedics AG | TC-PLUS Porous Femoral Components | K011258 | 5/24/01 | | PLUS Orthopedics AG | VKS Knee System | K022204 | 10/18/02 | Table 1: Cleared Predicate Devices : : : {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # NOV 2 0 2007 Smith & Nephew, Inc. % Mr. Rishi Sinha Regulatory Affairs Specialist Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 Re: K072858 > Trade/Device Name: TC-PLUS Primary 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: October 3, 2007 Received: October 5, 2007 Dear Mr. Sinha: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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 {3}------------------------------------------------ # Page 2 - Mr. Rishi Sinha CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Mel kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K072858 Device Name: TC-PLUS Primary Knee System Indications for Use: The TC-PLUS Primary Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasy. It is indicated for degenerative, post traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery. | Prescription Use
(Part 21 CFR 801 Subpart D) | X | |-------------------------------------------------|---| | AND/OR | | | Over-The-Counter Use
(21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Barbara Reclus (Division Sign-Of Division of General, Restorative, and Neurological Devices 510(k) Number 2072858 Page 1 of / --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K072858](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K072858) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com