(76 days)
Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis;
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
- · treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, and EMPOWR POROUS Tibia which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:
· absence or loss of both cruciate ligaments
- · moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon
- · bone loss that requires supplemental fixation in the clinical judgement of the surgeon
The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability.
The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate.
All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial insert.
This document is a marketing clearance letter from the FDA for a medical device, specifically a knee joint prosthesis. It does not contain information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML medical device.
The provided text discusses:
- The FDA's decision regarding substantial equivalence for the EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert.
- Regulatory information about the device (product code, regulation number, class).
- General controls provisions and additional controls that may apply.
- Indications for Use for the device, which describe the patient conditions for which the device is intended.
- A brief description of the device as a line extension offering increased constraint.
- Comparison of technological characteristics with a predicate device.
- Performance testing: This section lists types of performance tests conducted (e.g., CAD Based Range of Motion (ROM), Femoral – Tibial Contact Area Assessment, Femur - Tibial Intrinsic Stability, Femur - Tibial Varus / Valgus Constraint Testing, MR Conditional Labeling), but it does not provide acceptance criteria or the reported results of these tests. It merely states that "The following testing was performed to FDA recognized standards and internal protocols."
- Absence of animal or clinical studies: The document explicitly states "No animal data submitted" and "No clinical data submitted." This indicates that the substantial equivalence determination was based on non-clinical data, likely bench testing and comparisons to the predicate device.
Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment, as these pertain to performance studies that would typically be conducted for AI/ML medical devices or devices requiring clinical evidence for efficacy/safety.
The provided document is a 510(k) clearance letter, which often relies on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characterization, rather than extensive clinical trials or AI/ML specific performance studies. This specific device is a mechanical implant, not an AI/ML-driven diagnostic or therapeutic device.
§ 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.