Regulatory records and clinic reports answer different questions
PRECICE MAX: a dated evidence trail
A clearance, a recall record, and a clinic's use announcement each describe a different part of the story.
FDA 510(k) clearance
Substantial equivalence decision
K232267 describes larger nail and screw dimensions and nonclinical performance testing. Clearance is not proof of better long-term patient outcomes.
Recall initiated
Affected catalog and lot combinations
Recall Z-0500-2025 covers specified devices. The instructions distinguish affected unimplanted stock from monitoring of already implanted patients.
Provider-reported use
Paley Institute announces use of latest PMax
The institute reports a stature-lengthening procedure using the latest PMax. This is a clinic announcement, not independent comparative clinical evidence or proof of worldwide supply.
Checked 7 Oct 2026
The FDA recall record displayed Open, Classified. A later clinic announcement does not establish that every device, lot, or jurisdiction is available or unaffected by a recall.
For an individual device: confirm its exact model and lot, current instructions for use, local regulatory status, and the treating team's plan. Stronger mechanical test results do not by themselves establish a safe patient weight, a walking date, or fewer complications.
Original LLL editorial evidence map. English-language visual.