Baxter receives FDA clearance for posterolateral spinal fusion bone graft substitute: 4 notes

Biologics

Baxter International received FDA 510(k) clearance for its Altapore Bioactive Bone Graft for spinal fusion.

Here are four things to know:

1. The bioactive and osteoconductive bone graft substitute was previously cleared for orthopedic extremity and pelvis procedures.

2. Altapore is designed to enhance and accelerate bone growth with its proprietary silicate-substituted technology and micro- and macro-porosity. The bone graft substitute contains 0.8 percent silicon by weight.

3. Altapore can be used in posterolateral spinal fusion procedures when combined with autograft or autogenous bone marrow aspirate, as well as standalone bone graft substitute to fill bony voids or gaps.

4. The bone graft is designed to resorb and be replaced with bone during the healing process.

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