Medartis AG · Class II · Cleared Mar 7, 2025
| K-number | K243610 |
| Device name | APTUS Hand System; APTUS Elbow Dorsal Olecranon |
| Applicant | Medartis AG |
| Product code | HRS |
| Device class | Class II |
| Decision date | Mar 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The APTUS Hand System is a metallic bone fixation device used to treat fractures, osteotomies, and arthrodesis of hand bones including phalanges, metacarpals, and scaphoid. The APTUS Elbow Dorsal Olecranon Plates are fixation devices for fractures and osteotomies of the ulna. Both devices consist of plates compatible with locking screws (TriLock), cortical screws, and self-tapping screws (SpeedTip), available in non-sterile or sterile forms.
The subject devices use identical materials and manufacturing steps as predicate devices, including titanium alloy (ASTM F136), stainless steel (ASTM F138), and unalloyed titanium Grade 4 (ASTM F67). TriLock screws feature a spherical three-point wedge locking design for friction-lock connections. SpeedTip screws have self-cutting tips requiring no prior drilling. Plates are anatomically pre-contoured and accommodate both locking and non-locking screws with the same operating principle and basic design as predicates.
ASTM F543 was used to evaluate screw torsional properties, driving torque, axial pullout, and self-tapping performance. ASTM F136 specifies titanium-6 aluminum-4 vanadium alloy for surgical implants. ASTM F138 specifies stainless steel wire for surgical implants. ASTM F67 specifies unalloyed titanium Grade 4. Moist heat sterilization process was cleared under K232144.
The subject devices use identical final finished components, materials, and manufacturing processes as their predicates (K051567, K102537, K240613). Performance testing demonstrated that new APTUS Hand System plates do not represent a new worst case compared to predicate devices when evaluated per ASTM F543. The Elbow Olecranon devices are unchanged from K240613. Sterile versions utilize the same sterilization method and packaging materials as K232144. Since the devices maintain identical design, materials, operating principles, and indications for use as their predicates, and testing confirms equivalent safety and performance, they are substantially equivalent.
View the full FDA submission: accessdata.fda.gov