These seven ALIF cages have already received U.S. Food and Drug Administration (FDA) 510(k) clearance or CE Mark approval . Most of them have started with the first surgeries or they will be launched during the next months.
On April 29, 2020 Astura Medical, received 510(k) clearance from the U.S. Food and Drug Administration (FDA)for its El Capitan Anterior Lumbar Interbody Fusion (ALIF) System.
The El Capitan Anterior Lumbar Interbody Fusion System is a comprehensive system that provides a complete range of anatomic spacers and fixation options for rigid anterior lumbar 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.
El Capitan was designed to provide the widest array of interbody and fixation options, along with the most efficient and streamlined supporting instrumentation on the market today.
Expanding on the foundation of success from the company’s previous interbody spacer technologies, El Capitan provides the choice of either HA PEEK or Acid-etched Titanium interbody spacers in an extensive array of heights, widths, and lordotic options.
The system also provides the flexibility for additional plating and fixation options in an effort to tailor to the specific needs of each patient. The plating options from El Capitan allow for a Zero-Profile, Half Plate, or Full Plate that can be implanted in combination with the interbody. By providing either Anchoring Nails or Screws, which can be delivered via multiple techniques including an All-in-One option, El Capitan can accommodate the wide variance of anatomical challenges presented in anterior lumbar surgery.
2.-ASTS-SA | 4WEB Medical
On June 9, 2020, 4WEB Medical, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device (ASTS-SA).
The new design allows fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the need for supplemental fixation. Additionally, the device features single-step locking mechanisms that provide surgeon users confidence in the performance of the stand-alone construct. The anterior lumbar stand-alone product line will be available in multiple footprints, lordotic angles, and heights. The product line will be delivered in sterile packaging for hospital efficiency and patient safety.
Consistent with 4WEB’s existing product portfolio, ASTS-SA has an Advanced Structural Design that incorporates the company’s proprietary Truss Implant Technology™. Under normal loading conditions, the struts in the truss implant transfer strain to adjacent cellular material which stimulates a mechanobiologic response.
On May 28, 2020 Life Spine announced the first surgeries with the DYNA-LINK Ti Stand-Alone ALIF Spacer System.
DYNA-LINK Ti features Life Spine’s proprietary OSSEO-LOC™ surface technology and large, open graft windows. The system comes in footprints of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. Additionally, there are three lordotic options of 6°, 12° and 18° and heights ranging from 11-17mm. The screws allow for stand-alone use of the system and offer angulation up to 45°. However, the system can also be utilized with barbs, which feature teeth and a threaded head designed for ease of removal, if supplemental fixation is utilized.
4.-HEDRON IA ALIF | Globus Medical
On Feb. 04, 2020 Globus Medical, announced Dr. Joshua S. Rovner became the first spine surgeon to implant HEDRON IA, a 3D printed integrated ALIF spacer that leverages anchors or screws for vertebral body fixation.
HEDRON IA™ is a 3D Printed Integrated ALIF spacer that features a biomimetic porous scaffolding designed to encourage cellular response and promote bone formation onto and through the implant.
HEDRON 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.
Nexxt Spine announced on May 28th, 2020 the U.S. Food and Drug Administration FDA 510 (k) clearance of their ALIF 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 ALIF. 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: ALIF in August 2020
6.-ALIF | Axis Spine
On May 27, 2020, Axis Spine Technologies received FDA 510(k) clearance to market the Axis-ALIF, their first implant system.
Axis has developed a platform technology of build in situ modular cages as an alternative to conventional cage designs. Modular endplates are inserted in a closed position, atraumatically helping to preserve the structural integrity of the vertebral endplate.
Once in situ, the appropriate modular core is inserted and locked. Multiple combinations of endplates and cores offer numerous sagittal as well as coronal correction capabilities.
7.-BIG® ST ALIF Cage | SIGNUS
On the 9th of April 2020, Signus Medizintechnik announced CE Mark approval for the BIG® ST ALIF Cage.
With the CE approval of the BIG® ST ALIF Cage, SIGNUS expands their ST (Structural Titanum) product portfolio of 3D printed cages. The lumbar cage can be inserted either from anterior or minimal invasive from retro/ transperitoneal. With it ́s open porous structure BIG® ST comes along with the same excellent osteocunductive characteristics as the other implants oft he ST-Line by SIGNUS.
Besides the traditional ALIF approach, BIG® ST can also be inserted in 45° oblique or 90°lateral technique. Implanted from anterior it is possible to insert four divergent fixation screws and use it as a stand- alone fusion device which comes along with both economic benefits and less invasive surgery for the patient. With its wide range of implant sizes and lordotic angles a restoration of disc height and sagittal profile is ensured.
The flattened front edge and the smooth lateral surfaces combined with the self distracting design ensure a reduced preparation and protection of the nerval structures while inserting.The open macroporous structure resembles natural cancellous architecture and enables both – growing on and growing in of bone that can be supported by filling the implant with KAINOS® Inject.
An increased roughness in conjunction with the proven SIGNUS toothed cage design secures the anchoring in the bone owing to a high primary stability and reduces the risk of implant migration. The large contact area with the vertebral body reduces the risk of subsidence.All implants are in individual sterile packaging and for immediate use.The system is completed with sophisticated and easy-to-use instruments.