Summary
The selected FDA evidence includes nine 510(k) decisions associated with the displayed families. One of those decisions, K242834, covers the System 9 Sterile Battery Container only. It does not establish clearance of every tool or accessory in that platform. [4][5][6][7][11][12][10][8][9]
Surpass Evolve is documented through PMA supplement P170024/S003, and LIFEPAK 35 through P160026/S040 under Physio-Control. These are product-specific supplement approvals, not two new original PMAs; they are excluded from the original-PMA count. Other FDA records retain applicants such as Howmedica, Mako Surgical and Inari Medical. [3][2][6][4][8]
FDA records report open recall events involving specified Mako components/software, Triathlon components or instruments, ProCuity beds, LIFEPAK products/accessories and Trevo NXT products or kits. The expandable records identify documented events; affected models, lots and corrective actions must be checked in the FDA sources. These findings do not establish that every current model is recalled. [24][18][23][25][29][15][16][21][19][28][13][20][26][27][17][22][14]
Counts are documented minimums. Some recall mappings involve older configurations. ProCuity premarket status and the De Novo review remain unresolved. [72]