(87 days)
The Stabil Orthopaedic Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The Stabil Orthopaedic Solutions Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Stabil Orthopaedic Solutions Total Knee System is designed for cemented use only.
The Stabil Orthopaedic Solutions Total Knee System is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Stabil Orthopaedic Solutions Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
This document describes a 510(k) premarket notification for the Stabil Orthopaedic Solutions Total Knee System. The core of this submission is a claim of substantial equivalence to a predicate device, the Progressive Orthopaedic Total Knee System (K142649/K150783), rather than a study proving the device meets de novo acceptance criteria.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable in the sense of a new clinical or diagnostic validation study for the Stabil Orthopaedic Solutions Total Knee System itself. Instead, the "acceptance criteria" here are met by demonstrating identicality to an already cleared device, and the "study" is the preclinical performance testing previously conducted for the predicate device.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim based on identicality to a predicate device, the "acceptance criteria" are implied by the predicate device's prior clearance and its successful preclinical testing. The reported performance of the subject device (Stabil Orthopaedic Solutions Total Knee System) is that it is identical to the predicate device and thus its performance aligns with the predicate's established performance.
| Acceptance Criteria (Implied by Predicate Clearance) | Reported Device Performance (Stabil Orthopaedic Solutions Total Knee System) |
|---|---|
| Fatigue performance of the tibial tray is acceptable | Identical to predicate device which demonstrated acceptable fatigue performance. |
| Interlock mechanism strength of the tibial tray and insert is acceptable | Identical to predicate device which demonstrated acceptable interlock mechanism strength. |
| Shear fatigue strength of the tibial insert post is acceptable | Identical to predicate device which demonstrated acceptable shear fatigue strength. |
| Tibiofemoral contact area and stress are acceptable | Identical to predicate device which demonstrated acceptable tibiofemoral contact area and stress. |
| Tibiofemoral constraint is acceptable | Identical to predicate device which demonstrated acceptable tibiofemoral constraint. |
| Patellofemoral constraint is acceptable | Identical to predicate device which demonstrated acceptable patellofemoral constraint. |
| Range of motion is acceptable | Identical to predicate device which demonstrated acceptable range of motion. |
| Materials are safe and effective for intended use | Identical to predicate device which uses identical materials deemed safe and effective. |
| Design features are safe and effective for intended use | Identical to predicate device which has identical design features deemed safe and effective. |
| Indications for use are appropriate and align with predicate | Identical to predicate device's indications for use. |
| Manufacturing methods are acceptable | Utilizes manufacturing methods identical to the predicate device. |
| Packaging and sterilization processes are acceptable | Utilizes packaging and sterilization processes identical to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not directly available for the Stabil Orthopaedic Solutions Total Knee System as no new testing was performed for this specific submission. The submission relies on "Extensive preclinical testing performed on the predicate devices per K142649 and K150783." The sample sizes and detailed provenance of those predicate device tests are not provided in this document. The tests mentioned (fatigue, strength, contact, constraint, range of motion) are typically bench tests (laboratory testing) rather than clinical studies with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" here is established through engineering and biomechanical performance standards, not through expert consensus on diagnostic images or clinical outcomes. These are typically assessed by engineers and testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept typically refers to the resolution of discrepancies among expert opinions in clinical or diagnostic studies. For mechanical and material testing, results are typically quantitative and compared against predefined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a total knee replacement system, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are not relevant to its assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the predicate device's performance testing (which this submission relies upon) would be defined by biomechanical and material science standards and specifications. For example:
- Material properties: Measured against ISO or ASTM standards for UHMWPE, cobalt-chromium, titanium alloys.
- Mechanical strength, fatigue, and wear: Measured against established biomechanical testing standards for knee implants (e.g., ISO 14243 for wear, ISO 21536 for knee joint prostheses).
- Geometric and dimensional accuracy: Measured against design specifications.
8. The sample size for the training set
Not applicable. This is a medical device (implant), not a machine learning model requiring training data.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning model.
§ 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.