Device Information

The E3D-A Interbody System’s implants are available with and without HA^nano Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment that presents nano-scale topography on the entirety of the implant surface.

Indications

The E3D-A Interbody System is used in the thoracolumbar spine to treat conditions like degenerative disc disease (DDD), disc herniation, spondylolisthesis, and spinal stenosis. It supports fusion in patients with spinal deformities such as scoliosis and kyphosis or those with failed previous fusions. The degenerative disc disease (DDD) patients should be skeletally mature and have had at least six (6) months of non-operative treatment. 

Intended Use

The E3D-A Interbody System is intended for spinal fusion in the thoracic, thoracolumbar junction, or lumbosacral spine. It is designed for adult patients with conditions like degenerative disc disease (DDD) or deformity and is used with autograft or allograft bone. Surgeons can use this device with supplemental fixation, such as screw and rod systems, depending on the condition. Only qualified healthcare professionals can use this device.

Availability

The device is available by prescription only.

Limitations

When indicated, the device must be used with supplemental fixation, especially for hyperlordotic implants with ≥20° lordosis. Long-term data on the device’s use in conditions other than those specified may be limited.

Study Results

Performance testing of the E3D-A Interbody System followed ASTM F2077 standards for dynamic compression shear testing. The device demonstrated performance comparable to predicate devices.

Regulatory Information

• The E3D-A Interbody System meets the FDA requirements for labeling, medical device reporting, and quality system regulations.
• This device is a Class II device under the FDA’s regulatory framework.

Manufacturer Information

• Name: Evolution Spine
• Address: 2300 N Haskell Ave, Dallas, TX 75204
• Contact: Todd Wallenstein, VP of R&D, Quality, and Regulatory

Predicate Device Information

• Predicate Device Name: EVOLUTION SPINE Interbody System
• 510(k) Number: K223146
• Is the predicate device an earlier version of the same device? Yes
• Reference devices K201614 (TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc.), K222561 (Align Anterior Cages, Acuity Surgical Devices, and K220782 (IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Alphatec Spine).

Implications

The E3D-A Interbody System provides surgeons with a reliable device for spinal fusion in patients with degenerative conditions. It offers flexibility in terms of its use with supplemental fixation and compatibility with both autograft and allograft bone. The HA^NANO Surface enhances bone integration, making it a valuable option for improving fusion outcomes.

References

1. E3D-A Interbody System. K232432. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232432
2. Manufacturer website: Evolution Spine

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• Medical Specialties: Orthopedics, Spine Surgery
• All Others: Intervertebral fusion, Degenerative Disc Disease (DDD), spinal deformity, autograft bone, supplemental fixation, spinal fusion, HAnano Surface.