Elevation Spine has obtained US Food and Drug Administration (FDA) clearance for Saber-XA, an anterior lumbar interbody fusion (ALIF) system with an expandable cage for degenerative disc disease treatment and spinal column stabilisation.
Elevation highlighted that due to Saber-XA’s form factor, surgeons can independently adjust the implant’s height angle based on individual patient anatomy.
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FDA clearance for Saber-XA comes weeks after the California-based company secured FDA clearance for Saber-C AVIA, a cervical fixation device to treat spinal pathologies including nerve compression by stabilising the vertebrae, damaged disc replacements, and to promote bone fusion.
Elevation’s CEO, Charlie Gilbride, commented: “This clearance represents exactly what we set out to achieve with Saber-XA: true intra-operative customisation of height and lordosis, something no competing ALIF system offers in combination with both spike and screw fixation along with an anterior lumbar plate.”
Trends and movement in the US spinal fusion market
GlobalData analysis reveals that the global spinal fusion market is growing at a compound annual growth rate (CAGR) of 1.4% and is projected to reach a valuation of around $17.5bn in 2035.
As this market continues to grow, there is a rising trend for interbody fusion systems with expandable cages, with this design giving surgeons more flexibility in undertaking procedures between varying patient anatomies.
Preceding Elevation’s latest clearance and its July clearance for Saber-C AVIA, Xenix Medical obtained FDA clearance for its Lux expandable lumber interbody fusion system in June and announced the product’s launch on the US market.
According to a GlobalData market model, in the US, the largest spinal fusion market share in 2025 was not occupied by major medtech firms, suggesting that an upswell of smaller manufacturers in this space are biting at the heels of the more established strategics.
On a single company basis, meanwhile, Medtronic led the US market in 2025 with a share of 21.6%, followed by Johnson and Johnson (J&J) subsidiary DePuy Synthes in second place and Globus Medical in third with market shares of 16.7% and 14.6%, respectively. With continued market growth, the US spinal fusion market is evidently primed for disruption, with the likelihood of this potential increasing as the future leadership of DePuy Synthes remains less certain at this time as J&J moves ahead with a spinoff of the subsidiary.
