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The VariAx Distal Radius Plating System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures. Indications include: compression fractures, intra-articular and extra-articular fractures, displaced fractures. Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: Internal fracture fixation; Osteotomies; Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below: T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: Compression fractures; Intra-articular and extra-articular fractures; Displaced fractures; Reconstruction procedures; T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of: Intra-articular and extra-articular fractures of the Distal Radius, Displaced and compression fractures of the Distal Radius; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Reconstruction procedures in the Foot & Ankle and Distal Radius; T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of: Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; Single, segmental and comminuted fractures; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Normal bone density or osteopenic bone.

This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx Distal Radius Plates. The components of the VariAx Distal Radius System remain identical to those in the most recently cleared in K141430. No new components have been added to the system.

Briefly, the VariAx Distal Radius Plating System consists of several different plates and screws manufactured from Commercially Pure Titanium Grade 2 (ASTM F67) and Titanium Alloy (ASTM F136), respectively. The VariAx 2 System (screws) (cleared under K140769) include a series of Titanium Alloy (ASTM F136) screws intended to be used across the entire VariAx line. The VariAx 2 T8 2.0 mm peg, T8 2.4 mm and T8 2.7 mm screws, and washer are specifically indicated for use with VariAx Distal Radius Plating System. All implants are provided sterile and non-sterile.

The new packaging configuration, called the VariAx 2 Xpress Distal Radius Kit, includes already cleared sterile packed VariAx Distal Radius Plates and VariAx 2 T8 2.7 mm screws along with single use class I exempt instrumentation.

This document is a 510(k) summary for a medical device submission, specifically for the VariAx Distal Radius Plate System and VariAx 2 System.

The FDA 510(k) clearance process is for demonstrating substantial equivalence to a predicate device, not for proving a device "meets acceptance criteria" in the way one might prove performance of a new diagnostic algorithm. This specific document states that no clinical or non-clinical testing beyond LAL testing was required for this submission because the changes are primarily related to packaging configuration and no new components have been added. The products themselves remain identical to previously cleared predicate devices (K141430 and K140769).

Therefore, the information you've requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details do not apply to this specific 510(k) submission. This document explicitly states:

• "No additional non-clinical laboratory testing was required for this submission as there are no new components being added to the system." (Page 8)
• "Clinical testing was not required for this submission because there are no new components being added to the system." (Page 8)

The "acceptance criteria" for this submission are simply that the new packaging configuration does not alter the fundamental safety or effectiveness of the previously cleared components.

Given the nature of this 510(k), I cannot generate the requested table or answer the specific questions about performance studies, as such studies were not part of this particular submission. The device's "performance" was established by the original predicates it references, not by new studies for this packaging change.

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