PRECICE Max

The Max is a PRECICE nail at heart. The FDA 510(k) summary (K232267) describes the same principle of operation, distraction osteogenesis driven by a magnetic mechanism, the same titanium alloy (Ti-6Al-4V ELI, ASTM F136), and compatibility with the existing External Remote Controllers, ERC 1 through ERC 4P. Your daily routine is therefore the PRECICE routine: short sessions holding the controller over the magnet, on a prescribed schedule, with X-rays to check the regenerate. See the PRECICE 2 page for the session-by-session detail.

What changed is size. The 510(k) lists two technological differences from its predicate: a larger nail diameter and a larger screw diameter. Globus Medical's product page gives nail diameters of 10, 11.5 and 13 mm, partially threaded screws designed for bi-cortical purchase, and larger distal screw holes than PRECICE 2. The company claims a 2.6-fold improvement in dynamic bending strength and 1.3-fold in rotational stability over PRECICE 2, footnoted as "mechanical testing data on file". Those are bench figures, not patient outcomes.

The indications are identical to the current PRECICE label: limb lengthening, fracture fixation, non-unions and bone transport of long bones in patients 18 and older, and femur or tibia lengthening in children over 12. The Max is pitched at the patient PRECICE 2 serves awkwardly: heavier, taller, or planning bilateral femurs and unwilling to spend months on crutches. Whether it delivers that depends on a weight-bearing allowance the manufacturer has not published on its product page; the strength multipliers are the only numbers offered.

Exclusions follow the family. The FDA's June 2023 letter on titanium PRECICE devices tells surgeons not to implant in patients under 50 lb or above the IFU's maximum weight, not to implant more than two devices at once, and to remove the device after one year. The canal must take a 10 to 13 mm nail, which a narrow canal may not accept. And because the drive is a magnet, the questions that apply to PRECICE 2, pacemakers and MRI access, apply here; ask to see the Max IFU pages on both before you sign.

Distraction follows the PRECICE pattern: a latency period, then daily sessions at a rate the surgeon sets from the X-rays, then consolidation with the nail acting as an internal splint. The Max nails are offered in several designs and lengths, per the 510(k), and this site's method table lists the same 5 to 8 cm typical gain as PRECICE 2, because the biology of new bone does not change with a thicker nail.

The clock for removal is the same too. The FDA's standing reminder for the titanium PRECICE family is that the device should be removed after one year, and a nail that has done its job is a second operation waiting to happen. Where the Max may differ is what you are allowed to do in between. The surgeon who performed the first implantation said the nail would let stature-lengthening patients "bear full weight throughout their lengthening and consolidation process". That is a surgeon's statement in a press release, not a line from the labeling, and you should ask which one your clinic is following.

Two facts sit above every brochure claim. First, on 30 September 2024 Globus Medical, the current owner of NuVasive Specialized Orthopedics, recalled the Max. The FDA record (Z-0500-2025, Class 2) cites "potential issues with design, manufacturing and documentation issues related to the validation of the affected products", covers 164 devices distributed in Florida and Nevada, and records that customers were told to monitor implanted patients closely, stop using unimplanted devices and return remaining stock. As of September 2026 the FDA lists the recall as open. Second, we found no peer-reviewed outcome series on the Max in PubMed.

What you can lean on is class data. The 2021 systematic review of 983 motorized-nail segments (mostly PRECICE) reported complications in 34% of segments, permanent sequelae in 3%, and distraction-mechanism failure, joint contracture and delayed healing at about 5% each. The Max is titanium, not the stainless steel of the recalled Stryde, and the FDA said in June 2023 that it was not aware of biocompatibility-related adverse events in titanium PRECICE devices while continuing to monitor. A stronger nail does not remove the risks that come from the bone, the nerves and the joints, and it adds an unknown of its own.

Expect the Max to be quoted at the top of the internal-nail band, above PRECICE 2 at the same clinic. The drivers are ordinary: a newer, larger implant; two nails for a bilateral case; the ERC; a removal operation inside a year; and a distribution footprint that in the 2024 recall record covered two US states. Scarcity and novelty both push quotes up, and neither is a clinical benefit. A recall on the record is a reason to ask about pricing, not to pay more.

What the price should buy you is a written protocol and follow-up, including the removal operation and the imaging between. If a quote for the Max is not clearly above the same clinic's PRECICE 2 quote, ask which implant is actually going in. If it is far above, ask what the extra pays for beyond the implant invoice.

Questions to ask. Was your Max inventory part of the September 2024 recall, and what did Globus tell you? What weight-bearing protocol will I follow, and is it from the IFU or the surgeon's own practice? How many Max cases have you completed, and can I see your complication log, given that no published series exists? Do you or your institution have a development or financial relationship with the manufacturer? The surgeon who led the first implantation states in his institute's press release that he contributed to developing the nail; that is a legitimate thing to know, not an accusation.

Red flags: a guarantee of full weight-bearing from day one; "Max is Stryde without the problems", which conflates a different metal with proven safety; long-term outcome claims for a device implanted since 2024; a clinic outside the United States quoting the Max without stating its regulatory status in that country; and any reluctance to show you the IFU.