FAQ: PRECICE Nail and LON — Device-Specific Questions

No. PRECICE MAX received U.S. 510(k) clearance in December 2023, but a 2024 Class II recall covers specified catalog and lot combinations. The FDA record remained open when updated on July 14, 2026 and told customers to stop using and return affected unimplanted devices. That record does not establish the status of every later or current unit. Verify the exact catalog number, UDI or lot, current instructions, recall status, actual availability, and permitted load; clearance alone does not establish full weight-bearing or suitability. [1][5]

The exact model and diameter must fit the bone length, canal, curvature, cortex, entry approach, osteotomy, and fixation plan. Measurements are matched to current manufacturer instructions. A generic list of old diameters or a single CT cutoff cannot select the implant for a patient.

Appropriate implant selection and fixation, alignment, adherence to the written load restriction, safe transfers, monitoring, and response to pain or device findings all matter. Patient compliance is not the only factor, and following restrictions cannot guarantee that a mechanical event will not occur.

Eligibility depends on the current labeling for the exact system plus anatomy, age, weight, number of implants, infection, bone quality, canal and bone dimensions, deformity, soft-tissue depth, medical risk, and ability to follow the protocol. The FDA guidance includes age, patient-weight, implant-count, and removal instructions. [2]

No. Stroke is a model-specific mechanical maximum. Joint motion, nerves, muscles, regenerate, alignment, rehabilitation, and patient goals can require stopping well before the mechanism reaches its limit.

Unexpected pain, controller errors, disagreement between programmed and radiographic distraction, alignment change, or an unusual sensation should be reported. Some problems are visible only on imaging or require technical evaluation. Do not repeat extra controller sessions to test or compensate for a suspected problem.

Distraction rhythm is a clinical prescription and may need to slow or pause. Faster travel is not a biological indication to increase it. The team should define the starting rhythm, monitoring cadence, and exact joint, nerve, regenerate, alignment, or device findings that change the plan.

Possibly under a provider-specific plan, but possession of the controller is not a remote-care system. Diagnostic imaging, measured function, a local examination and emergency pathway, clinician ownership, response times, and the ability to return for urgent intervention must be arranged before surgery.

LON places an intramedullary nail and an external fixator during distraction. The frame performs the distraction. At the planned transition, the nail is locked and the frame is removed so the nail supports consolidation. The overlap of pin sites and an intramedullary implant creates a distinct deep-infection concern. [3]

Not as a universal rule. A central purpose of LON is to shorten external-fixator duration by transferring stabilization to the locked nail after distraction. Transition timing and any delay depend on regenerate, stability, infection, alignment, and the surgeon's protocol.

Programmed movement and radiographic bone separation can differ because of positioning, compliance in the construct, technique, or malfunction. The magnitude and cause cannot be safely inferred from a general soft-tissue explanation. Serial imaging and the treating team determine whether progress is acceptable.

Incisions and pin or wire sites depend on the nail, frame, bone, approach, fixation, and any additional procedure. Scar size, pigmentation, widening, tethering, and symptoms vary. Request the planned incision and pin map; do not rely on a universal count or centimeter estimate.

Only according to the individual therapy and surgical plan. Fit, skin, nerve symptoms, pain, sleep, motion, and current alignment matter. Discomfort is not automatically a reason to continue unchanged or to stop; contact the therapist or surgeon for adjustment.

Management depends on whether the finding is mechanical irritation, superficial infection, pin loosening, deep infection, or osteomyelitis. The team may need examination, culture, imaging, local care, antibiotics, pin intervention, debridement, or a fixation change. A website should not supply a stepwise antibiotic protocol.

Reported rates vary dramatically with definition, frame, pin, population, duration, and denominator. Ask the center for its own superficial, deep, and bone-infection rates for the proposed method. In a small randomized LON study, 3 of 15 LON limbs developed deep intramedullary infection, which shows why both frame-time benefits and infection risk belong in consent. [4]