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APTUS Hand
Fractures, osteotomies and arthrodesis of the bones of the hand

• Hand System
• fractures of the distal, middle and proximal phalanges
• fractures of the metacarpals
• osteotomies of the hand
• arthrodeses in the hand
• Scaphoid plates
• fractures and non-unions of the scaphoid
  The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device includes the APTUS Hand System, which is used for fractures and arthrodesis of the bones of the hand. APTUS Hand plates are offered in two main system sizes, 1.2/1.5 and 2.0/2.3, depending on the screw size. The subject device plates are to be used with Medartis APTUS TriLock locking screws and SpeedTip screws.

• Non-locking plates 1.2/1.5 use cortical screw sizes of either 1.2 or 1.5 mm, and SpeedTip screw size of 1.5mm
• TriLock locking plates 1.2/1.5 use locking screws sizes of either 1.2 or 1.5 mm, but also accepts cortical screw sizes of 1.2 or 1.5mm as well as SpeedTip screw size of 1.5mm
• TriLock locking plates 2.0/2.3 use locking screws size of 2.0 mm, but also accepts cortical screw sizes of 2.0 or 2.3 mm
  The APTUS Hand plates are anatomically pre-contoured with respect to the anatomy of the specific bone they are designed for. Most plates may be additionally cut and bent intraoperatively for a wide range of applications.
  The subject device screws consist of non-sterile TriLock Screws (locking)and SpeedTip Screws ( non-locking). TriLock Screw heads have spherical three point wedge locking design to create a friction-lock connection through radial bracing of the screw head in the plate, thereby creating uniform distribution of stresses over the screw head and plate. The SpeedTip Screws feature a self-cutting screw tip for insertion without prior drilling.
  The subject device plates are compatible with washers, screws and k-wires previously cleared K102537 (for washers and screws) and K092038 (for k-wires).
  Plate designs are available either non-sterile. Plates provided non-sterile are intended to be sterilized by the end user before use.
  The 510(k) of the subject devices K051567 and K102537 APTUS Hand Group and K234062 APTUS Hand Scaphoid will be grouped in the APTUS Hand System. As a result, the indication will be updated for better clarity. This change does not affect the design, materials, or functionality of the devices.
  APTUS Elbow Dorsal Olecranon Plates
  The purpose of this 510(k) submission is to obtain marketing clearance for the APTUS Elbow Dorsal Olecranon Plates to expand the range of Medartis APTUS fixation devices provided to the end user in a sterile condition. The non-sterile devices were previously cleared under K240613.
  The sterilization process proposed for the APTUS System has also already been cleared under K232144, Sterile Products of the APTUS System, the reference device for this submission.
  The Indication for Use, the Design and the Material are the same as in the previously cleared predicate device K240613 APTUS Elbow Dorsal Olecranon Plates.
  Sterile Products of the APTUS Elbow Dorsal Olecranon screws are made of titanium alloy conforming to ASTM F136 Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Sterile products of the APTUS Elbow Dorsal Olecranon K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18 Chromium -14 Nickel-2.5 Molybdenum Stainless Steel Wire for Surgical Implants (UNS S31673),
  Sterile products of the APTUS Elbow Dorsal Olecranon washers are made of unalloyed titanium, Grade 4, conforming to ASTM F67.

This FDA 510(k) summary does not contain information about acceptance criteria and a study proving a device meets them. Instead, it describes metallic bone fixation appliances and accessories (plates, screws, and washers) for fractures and arthrodesis of the bones of the hand and ulna. The submission argues for substantial equivalence to previously cleared devices based on similar intended use, operating principle, basic design, materials, and sterilization methods.

Specifically, it states:

• "Non clinical evaluation of the APTUS Hand System plates and screws and the APTUS Elbow Olecranon devices demonstrated that the performance of the subject devices is substantially equivalent to the predicate devices in terms of safety and efficacy."
• "The performance testing of the APTUS Hand Plate System demonstrates the safety and performance of the screws by evaluating torsional properties, driving torque, axial pullout, and self-tapping performance with full insertion in accordance with ASTM F543 as well as the performance of the plates in combination with the screws in a comparison between the worst case devices from the subject and predicate devices."
• "The testing demonstrated that the new APTUS Hand System plates do not represent a new worst case when compared to predicate devices."
• "No new testing of the APTUS Elbow Dorsal Olecranon was conducted as there were no changes to the design, materials, or manufacturing processes in the current submission."
• "Clinical data was not required to establish substantial equivalence of the predicate devices."

Therefore, I cannot provide the requested information.

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