(89 days)
The Allegretto Unicompartmental Knee system is intended to replace the medial or lateral compartment of the femorotibial knee joint, damaged as a result of non-inflammatory joint disease or trauma.
The system is an intermediate solution between osteotomy and a total prosthesis, and is indicated in cases of predominantly unicompartmental degeneration in which there is a fairly intact capsular ligament (CL) system.
The Allegretto Unicompartmental Knee system is indicated for use in treatment of:
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- Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies.
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- Passively correctable valgus-varus deformity and moderate flexion contracture.
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- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
The Allegretto Unicompartmental Knee system consists of a metallic distal femoral resurfacing component and a polyethylene proximal tibial resurfacing component. The device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint (medial or lateral) is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant intended for implantation with bone cement.
The femoral resurfacing component employs a symmetrical device design that can be used in left or right orientations. The component also features a radius of curvature to reproduce knee morphology for optimal bone coverage and a better kinematic, and two cruciate pegs to aid in its rotational stability. The femoral component is manufactured from Protasul™-2, a CoCrMo alloy that conforms to ISO standard 5832-4 and ASTM F 75.
The femoral component is also available in a distally reinforced version that is identical to the component described above with the exception of an additional 2mm buildup of material on the distal portion of the component. This additional material provides a better fit for patients with pronounced wear of the femoral condyle due to aseptic necrosis, revision, or dysplasia (valgus gonarthrosis).
The tibial component is manufactured from Sulene™-PE, an Ultra-High Molecular Weight Polyethylene (UHMWPe) that conforms to ISO 5834-1,2 and ASTM F 648. The allpolyethylene tibial component features universal geometry that allows it to be used in left and right knee applications. The superior articulating surface is basically flat, with a slight articulating surface curve to increase the bearing surface of the femoral component. A recessed groove pattern on the inferior surface of the device assists in fixation with bone cement. In addition, radiolucent wire is molded into the poly to assist in radiographic location.
This looks like a 510(k) premarket notification for a medical device submitted to the FDA in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with acceptance criteria and performance metrics in the way a modern AI/ML device submission would.
Therefore, the provided document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies because these are generally not components of a 510(k) submission for mechanical implants like the Allegretto Unicompartmental Knee System.
Instead, the submission focuses on:
- Product Description: Detailing the components, materials, and design of the Allegretto Unicompartmental Knee System.
- Intended Use/Indications for Use: Clearly stating the conditions for which the device is designed (e.g., unicompartmental noninflammatory degenerative joint disease, trauma).
- Substantial Equivalence: Listing predicate devices (Stryker Howmedica Osteonics SCR Unicompartmental Knee, Sulzer Orthopedics Natural Knee Uni Knee, etc.) and asserting that the Allegretto device is similar in intended use, materials, design, and operational principles. The FDA's letter (K011954) confirms this substantial equivalence.
In summary, the device's "acceptance" here is based on its similarity to already legally marketed predicate devices, implying that their established performance and safety profiles are sufficient for the new device. No new clinical study proving performance against defined acceptance criteria is referenced or required for this type of submission.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.