(56 days)
The Stryker Scorpio Total Knee system components are intended for the replacement of the bearing and/or articulating surfaces of the distal femur and proximal tibia to remove pain, instability, and restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma. The devices are intended for single-use only, and are intended for cemented fixation in patients indicated for total knee arthroplasty.
The devices included in this submission are tibial inserts, and all-polyethylene patellar components used in total knee arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior premarket submissions and are commercially available.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA regarding a change in labeling for orthopedic knee implants (Scorpio Universal Dome Patella, Scorpio Total Stabilizer Insert, Scorpio-Flex Posterior Stabilized Tibial Insert, Scorpio-Flex Cruciate Retaining Tibial Insert, Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert, Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert).
The key takeaway from the document regarding the submission is:
- Reason for 510(k) Submission: "The purpose of this "Change Being Effected" bundled submission is to add a contraindication to the labeling of the subject Scorpio Total Knee System." (Page 7)
- Non-Clinical and Clinical Testing: "Non-Clinical testing was not required as a basis for substantial equivalence." and "Clinical testing was not required as a basis for substantial equivalence." (Page 10)
This means the submission is primarily administrative (a labeling change) and does not involve new performance testing or studies. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document.
§ 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.