PRECICE MAX: Design, Weight Bearing, Recall, and Current Use

Status checked October 7, 2026

What is different from earlier PRECICE nails?

The FDA's K232267 summary describes a titanium-alloy system with larger nail and screw diameters than its predicate. Globus's current product page lists 10, 11.5, and 13 mm nails and larger distal screw holes with partially threaded screws. These are design descriptions, not evidence that every patient can walk without assistance. ^{[1] [3]}

Globus reports 2.6 times the dynamic bending strength and 1.3 times the rotational stability compared with Precice 2, supported by mechanical testing data on file. Those ratios describe the manufacturer's bench comparison. They do not mean 2.6 times the safe body weight, faster healing, fewer complications, or a proven advantage in cosmetic satisfaction. ^[3]

Does MAX mean immediate full weight bearing?

An implant's mechanical strength, its labeling, and a patient's permitted activity are separate matters. Ask for the current instructions for the exact nail and a written loading plan addressing implant size, bone segment, body weight, surgical configuration, and healing. This review did not verify a current MAX-specific instruction manual supporting one universal kilogram or pound allowance. Older PRECICE or STRYDE instructions and internet protocols are not substitutes.

What have surgeons and specialist centers said?

The institute's PMax page describes Paley's role in its design. That development involvement is relevant context when interpreting his assessment. This page does not infer undisclosed financial relationships or rank surgeons. No verified MAX-specific statement from Dr. Donghoon Lee was identified in the sources reviewed; his general lengthening animation is included in the beginner surgery guide. ^[7]

What does the FDA recall record say?

Recall Z-0500-2025 was initiated September 30, 2024 and posted November 21, 2024. It lists particular catalog numbers, lots, and UDIs, with 164 devices in commerce, and potential design, manufacturing, and validation-documentation issues. The customer action includes monitoring implanted patients and ceasing use of affected unimplanted stock. ^[2]

The record does not establish that every later MAX device is affected or unaffected. Nor does it instruct every recipient to seek automatic removal. Patients and clinicians need to reconcile the exact device identifiers with current manufacturer and regulator information. A newer clinic announcement does not, by itself, close the older recall. ^[2]

Where is MAX currently being used?

The clearest dated use report found here is Paley Institute's July 14, 2026 announcement of a procedure with the latest PMax. Its exclusivity wording describes that announcement's date; this review does not establish worldwide exclusivity in October. Undated clinic pages are weaker availability signals. No reliable global active-case count or country-by-country stock register was identified. ^{[4] [5] [6]}

Before making travel or payment arrangements, obtain the planned model, catalog number and lot or UDI; the current instruction revision; local regulatory status; and written confirmation that the clinic can supply that specific device. Also clarify rehabilitation, complication management, and later implant removal. The cost guide helps compare complete written quotes.

What remains uncertain about outcomes?

The FDA summary describes nonclinical performance testing. The manufacturer page reports bench testing, while the cited use reports are clinic statements. In the sources searched for this review, a MAX-specific long-term comparative outcome series was not identified. Studies of older PRECICE or STRYDE implants cannot establish MAX-specific superiority. Better mobility during one stage would not by itself prove better bone healing, long-term function, or fewer reoperations. ^{[1] [3]}