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The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.

The Renovis Cannulated Screw System includes cannulated screws and washers, designed to provide secure fixation for various fracture, osteotomy and arthrodesis indications. All screws are cannulated for use over guide pins, allowing for accurate placement. Screws are available in a range of diameters and lengths in partially threaded designs. The system also includes washers to prevent the screw head from pulling through the cortex. The Renovis Cannulated Screw System implants are made from 316L stainless steel.

The provided text describes the Renovis Cannulated Screw System, a bone fixation device. The 510(k) submission states that "No performance testing is included in this application." Therefore, there is no study that proves the device meets acceptance criteria detailed in this document.

The submission focuses on establishing substantial equivalence to a predicate device (Synergy Cannulated Screw System) based primarily on similar intended use, operating principle, design, dimensions, packaging, sterilization directions, and biocompatibility, despite a difference in material composition. The manufacturer justifies this by stating that the use of 316L stainless steel for the Renovis system (compared to the predicate's 23Mn-21Cr-1Mo low nickel stainless steel alloy or Ti-6AL-4V titanium alloy) "does not raise issues of safety or effectiveness."

Given this, the following sections cannot be fully answered as no performance study was conducted.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

No test set was used as no performance testing was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no test set requiring ground truth was used.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No performance testing is included in this application."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this device is a physical medical implant (cannulated screw system), not a software algorithm.

7. The type of ground truth used

Not applicable, as no performance testing requiring ground truth was conducted.

8. The sample size for the training set

Not applicable, as this information pertains to machine learning models, and the device is a physical medical implant.

9. How the ground truth for the training set was established

Not applicable, as this information pertains to machine learning models, and the device is a physical medical implant.

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