According to Allied Market Research, the global interbody fusion cage market is projected to reach $2,309 million by 2023.The lumbar segment capture the highest share of about 30% and is expected to remain dominant throughout 2023. This is attributed to the growing popularity of lumbar spine fusion techniques due to their ability to provide long-term clinical outcomes and their effectiveness in treating spinal disorders.
The main trends in the Lumbar cages market are the following:
- Lateral and ALIF cages
- Stand Alone interbody fusion devices
- 3D printed titanium interbody spacers
- Expandable devices
These six lateral cages are state-of-the-art devices that have received U.S. Food and Drug Administration (FDA) 510(k) clearance in the last months. Most of them will be launched during the next months.
On April 14, 2020 Astura Medical, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sirion Lateral Lumbar Interbody Fusion (LLIF) System.
The Sirion Lateral Lumbar Interbody Fusion System is a comprehensive system that provides a complete range of anatomic spacers and fixation options for rigid lateral stabilization. The intuitive design of the system provides the versatility to accommodate a wide array of anatomical challenges to ensure an efficient, streamlined procedural sequence.
Building from the well-established success of previous systems within the company’s portfolio, Sirion provides interbody spacers in either HA PEEK or Acid-etched Ti in a wide range of lengths, widths, heights, and lordotic options. When additional fixation is required, lateral plating options in either a 1, 2, or 4 hole configuration are available, which can be implanted in combination with the interbody or in-situ after the interbody has been placed for maximum versatility.
From initial access with the retractor to the interbody and plating options, the Sirion LLIF System delivers unprecedented intraoperative flexibility and efficiency by providing a complete procedural solution for lateral surgery driven by surgeon preference.
2.- SAHARA Lateral 3D| STRYKER
Stryker announced on November 2019 the U.S. Food and Drug Administration (FDA) 510(k) clearance of its SAHARA Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.
SAHARA Lateral is the first ever 3D-printed lateral expandable fusion device and features passive expansion capabilities that are designed to allow surgeons to achieve up to 30 degrees of sagittal spinal correction in skeletally mature patients.
Utilizing a passive expansion mechanism, the implant can either be adjusted from a lateral approach intraoperatively or can adjust passively in a staged posterior approach following osteotomy.
SAHARA Lateral features Lamellar 3D Titanium Technology, which uses an advanced 3D printing method to create structures that were previously difficult or impossible to manufacture using traditional manufacturing techniques. Starting with a titanium powder, the SAHARA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a roughened surface architecture. Roughened titanium surfaces have been shown to demonstrate increased protein expression in contrast to smooth titanium surfaces.1-3
SAHARA Lateral complements the SAHARA Anterior Lumbar Expandable Stabilization System, a lordotic expandable device with integrated screw fixation. SAHARA Lateral is available in a variety of footprints, heights and lordotic offerings designed to more precisely match a patient’s anatomy and is intended to be used with supplemental fixation systems cleared for use in the lumbar spine.
Nexxt Spine announced on May 28th, 2020 the U.S. Food and Drug Administration FDA 510 (k) clearance of their 3D Lateral System.
It will showcase the innovative Nexxt Matrixx® 3D printed titanium technology unique to the company. Recognized for sound science behind each interbody, Nexxt Spine has created the desired pore size and geometry that is now available in Lateral. Coupled with a modulus of elasticity lower than PEEK, microroughened surface technology and a 75% porous lattice there is no question Nexxt Spine is commanding industry attention.
Forecasted Summer launch dates are as follows: Lateral in September 2020. An integrated plate system is expected to be launched for each product in Q4.
Cutting Edge Spine, announced on January 9th, 2020 the 510(K) clearance and commercial launch of the latest addition to its bioactive portfolio of interbody systems, the EVOL®ha-DLIF direct lateral interbody fusion system.
The EVOL®ha-DLIF is made of PEEK-OPTIMA HA Enhanced material supplied by Invibio Biomaterial Solutions. Cutting Edge Spine implants made with this material have demonstrated early onset bone formation and apposition to its implants.
Life Spine, announced April 21st, 2020 that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PROLIFT Lateral Fixated System.
“PROLIFT Lateral Fixated combines the innovation of the SENTRY® Lateral Plate with the technology of the Lateral PROLIFT Expandable System for a simplified Lateral procedure,” said Mariusz Knap, Sr. Vice President of Sales and Marketing for Life Spine. “The system has integrated fixation and cam locks which offer visual, tactile and audible confirmation of final locking. Additionally, PROLIFT Lateral Fixated can be post packed in situ through the inserter and offers an extensive range of footprints. This system is a key addition to our rapidly growing Expandable portfolio.”
PROLIFT Lateral Fixated comes in widths of 18mm and 22mm, heights ranging from 8mm to 19mm, three lordotic options and lengths of 40mm to 60mm in 5mm increments. It is complemented by Life Spine’s full Lateral portfolio including the CENTRIC® Plier Style Retractor and Lateral Disc Prep.
HEDRON L is a lateral cage that will be launched soon. HEDRON™ 3D printed titanium interbody spacers feature a biomimetic porous scaffold designed to promote bone formation onto and through the implant.Unlike first generation 3D printed implants, HEDRON strikes the optimal balance of strength and porosity through a sturdy frame and a pore size distribution similar to trabecular bone.