(84 days)
The Osteonics® Scorpio™ Posterior Cruciate Retaining (CR) Total Knee System consists of posterior cruciate retaining total knee replacement femoral components, with corresponding cruciate retaining tibial bearing components, specifically designed to articulate together. These devices are single use components, intended for cemented fixation, and indicated for use in total knee replacement when the posterior cruciate ligament is functional.
The Osteonics® Scorpio™ Total Knee CR Femoral Components are compatible for femoro-tibial articulation with the Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts and the Osteonics® Scorpio" Total Knee CR All-Polyethylene Tibial Components. The Osteonics® Scorpio" Total Knee CR Tibial Bearing Inserts are intended for use with the legally marketed Osteonics® Series 7000 Total Knee Tibial Trays and Osteonics® Omnifit® Total Knee Tibial Trays.
The Osteonics® Scorpio" Total Knee CR Femoral Components are intended for patello-femoral articulation with the Osteonics® Scorpio™ Total Knee Patellar Components. In addition, the Osteonics® Series 7000 Femoral Bone Augmentation Components are compatible with the Osteonics® Scorpio™ Total Knee CR Femoral Components.
Indications:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, ● rheumatoid arthritis or post-traumatic arthritis.
- . Post-traumatic loss of knee joint configuration and function.
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can . be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
Osteonics® Scorpio" Total Knee Posterior Cruciate Retaining Femoral Components: The Osteonics® Scorpio" Total Knee Posterior Cruciate Retaining (CR) Femoral Components are fabricated from cobalt chromium alloy, available in right and left configurations, with or without two interior fixation lugs, and are available with three different interior surface textures to supplement the cement fixation of the device: basic grit-blasted surface roughness, waffle pattern, and MicroStructured® porous coating. These femoral components achieve primary fixation by interdigitation of the PMMA bone cement with the surface texture and the apposing bone.
Osteonics® Scorpio™ Total Knee Posterior Cruciate Retaining All-Polyethylene Tibial Components: The Osteonics® Scorpio" Total Knee Posterior Cruciate Retaining (CR) All-Polyethylene Tibial Components are one-piece total knee replacement tibial components, fabricated from ultra-high molecular weight polyethylene (UHMWPE). The bearing surface of the Osteonics® Scorpio" Total Knee CR All-Polyethylene Tibial Components employ a single M/L radius. A radiographic locator wire is positioned in the distal end of the post and in the inferior/anterior side of the tray. The Osteonics® Scorpio™ Total Knee CR All-Polyethylene Tibial Components are intended for cemented fixation. Primary fixation is to be achieved through interface of the bone cement with the tibial post, which is of the swept back, keeled design.
Osteonics® Scorpio™ Total Knee Posterior Cruciate Retaining Tibial Bearing Inserts: The Osteonics® Scorpio™ Total Knee Posterior Cruciate Retaining (CR) Tibial Bearing Inserts are fabricated from ultra-high molecular weight polyethylene (UHMWPE). These tibial bearing inserts are assembled to the appropriate tibial tray intraoperatively via a locking wire mechanism. The bearing surface of the Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts employ a single M/L radius, and accommodate the bearing geometry of the Osteonics® Scorpio™ Total Knee CR Femoral Components. The Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts are intended for femoro-tibial articulation with the Osteonics® Scorpio™ Total Knee CR Femoral Components. This tibial bearing insert is designed to be assembled with the Osteonics® Series 7000 Total Knee Tibial Trays or the Osteonics® Omnifit® Total Knee Tibial Trays.
The provided text is a 510(k) Premarket Notification for the Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to existing predicate devices, not a study proving it meets acceptance criteria through clinical trials or performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a study, sample sizes, expert opinions, or comparative effectiveness with AI.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Device Performance: This document describes the device's design, materials, and intended use, and states that "Applicable performance testing demonstrates that the subject components perform at least as well as, if not better than, the predicate commercially available designs." However, it does not specify what those performance criteria were (e.g., wear rate, strength, range of motion, clinical outcomes) nor does it provide a table of reported performance against specific criteria. This type of detailed performance data is typically found in design verification and validation documents, which are usually proprietary and not part of the public 510(k) summary.
- Sample Size and Data Provenance: No clinical study or performance data with specific sample sizes is mentioned. The "performance testing" referred to is likely bench testing (mechanical, durability) to ensure the device meets engineering specifications and compares favorably to predicate devices, rather than human subject data.
- Number of Experts and Qualifications: Not applicable, as there's no clinical data or image-based diagnostic performance being assessed by experts.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is a knee implant, not an AI software or diagnostic tool that would involve human readers.
- Standalone Performance: Not applicable as there's no "algorithm" or AI component. The performance mentioned refers to the mechanical and physical performance of the knee implant itself.
- Type of Ground Truth: Not applicable in the context of diagnostic accuracy.
- Sample Size for Training Set: Not applicable. This document refers to a physical medical device, not a machine learning model.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is a regulatory filing for a knee implant, establishing its substantial equivalence to previously marketed devices. It does not include the detailed performance study data you've requested, which is typically generated during the design and development phase and may be summarized in broader terms within a 510(k) submission.
§ 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.