Search Results

The intended use of the subject MRS Pediatic Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components is identical to that of the Modular Replacement System. The Modular Replacement System was cleared via 510(k) #K952970. A second submission, reference 510(k) #K972401, was found substantially equivalent which expanded the indications for use for the system. The original indications for use were for oncology patients where radical resection of the distal femur/proximal tibia is required. The expanded indications for use are limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedure would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

As with the predicate Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component and the Kinematic II Rotating Hinge Knee Tibial Plugs, the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are single use devices. They are intended for cemented fixation only. The subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are intended to be used in conjunction with the commercially available components of the Modular Replacement System and the Kinematic II Rotating Hinge Knee System.

This Kinematic II Rotating Hinge Knee XXX-Small Tibial Bearing Component, Kinematic II Rotating Hinge Knee XX-Small Tibial Plug and the Kinematic II Rotating Hinge Knee XXX-Small Tibial Plug are currently marketed devices that are being modified components, MRS Pediatric Tibial Bearing Component, MRS Pediatric All Poly Tibial Component PT2 (XX-Small) and the MRS Pediatric All Poly Tibial Component PT1 (XXX-Small) are substantially equivalent to features of the predicate devices, which have been cleared for marketing via the 510(k) process. The modifications address both design and material specification changes. The MRS Pediatric Tibial Bearing Component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-1537. The MRS Pediatric All Poly Tibial Components are manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648. The intended use of the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are identical to that of the Modular Replacement System. These components are intended for cemented use only.

I am sorry, but based on the provided text, there is no information about explicit acceptance criteria or a study that evaluates the device's performance against such criteria. The document is a 510(k) premarket notification for a medical device (Kinematic II Rotating Hinge Knee) that has undergone modifications.

The document discusses:

• The proprietary and common names of the device.
• Its classification and regulatory class.
• The modifications made to certain components (changes in design and material specifications).
• The substantial equivalence to predicate devices.
• The materials used for the modified components (Cobalt-chromium alloy and ultra-high molecular weight polyethylene, conforming to ASTM standards).
• The intended use of the modified components, which is identical to the Modular Replacement System and the Kinematic II Rotating Hinge Knee System, and includes cemented use only.
• The indications for use, which were previously expanded to include limb salvage procedures for severe trauma, failed previous knee arthroplasties, and oncology indications.
• The device is a single-use device.

Crucially, the document does NOT contain:

• A table of acceptance criteria and reported device performance.
• Details about a study conducted to demonstrate the device meets any performance criteria (e.g., clinical trials, bench testing results, sensitivity, specificity, accuracy).
• Information on sample size, data provenance, expert consensus, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

This 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against specific acceptance criteria. The modifications are primarily related to design and materials, and the justification for substantial equivalence relies on existing clearances and the intended use remaining the same.

Ask a specific question about this device