TC-PLUS PRIMARY KNEE SYSTEM

• K Number: K072858
• Device Name: TC-PLUS PRIMARY KNEE SYSTEM
• Manufacturer: SMITH & NEPHEW, INC.
• Date Cleared: 2007-11-20 ( 46 days)
• Product Code: JWH
• Regulation Number: 888.3560
• Type: Abbreviated
• Panel: OR
• Reference & Predicate Devices: K011719 , K994146 , K000666 , K011258 , K022204

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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Smith & Nephew TC-Plus Primary Knee System. This type of submission relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than conducting new clinical studies with defined acceptance criteria and performance outcomes. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.

Here's why the provided text does not contain the requested information:

• Substantial Equivalence: The document explicitly states that the submission aims to demonstrate "Substantial Equivalence Information" to "previously cleared devices." This regulatory pathway for medical devices (510(k)) focuses on showing that a new device is as safe and effective as another legally marketed device, rather than requiring new clinical trials that establish independent performance criteria.
• Device Description: The core of the submission is combining existing, cleared components from two previous knee systems (VKS Knee System and TC-PLUS Solution Knee System) and standardizing their sizing. 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 incremental change does not typically necessitate new clinical trials to prove performance against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information because the document describes a 510(k) submission based on substantial equivalence, not a study evaluating device performance against pre-defined acceptance criteria.

The document details the following:

• Device Name: Smith & Nephew TC-Plus Primary Knee System
• Device Description: A tricompartmental total knee prosthesis comprising femoral, patellar, and tibial components with an ultra-high molecular weight polyethylene articular insert. It combines components from the previously cleared VKS Knee System and TC-PLUS Solution Knee System.
• Indications for Use: Cemented surface replacement in treating patients for primary total knee arthroplasty or revision knee arthroplasty. Specific conditions include degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis, loss of joint configuration, patello-femoral erosion, functional disability, patellectomy, and moderate deformities.
• Predicates:
  • 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)
• Regulatory Classification: Class II, 21 CFR 888.3560 (Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis).

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.