(99 days)
Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.
The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.
The Patient Matched Cutting Blocks are intended for single use only.
Subject of this premarket notification are Smith & Nephew's Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRI, CT, X-Ray).
This 510(k) submission for Smith & Nephew's Patient Matched Cutting Blocks is for a physical medical device (patient-specific surgical instrumentation) and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, training set, and ground truth establishment, are not applicable here.
§ 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.