Our technologies
Products
Bilateral fixation from a single lateral position. Two applications.
For healthcare professionals
Both Foundation Surgical implants are built around the same proprietary deployable staple mechanism, protected by issued and pending patents. Our focus is motion preservation, and when fusion is the right choice for a patient, we offer a lateral fusion system built on the same platform.
At a glance
| Specification | Vertiwedge® | Interwedge® |
|---|---|---|
| Procedure | Vertebral Body Osteotomy (VBO®) | Lateral lumbar interbody fusion |
| Implant location | Within a single vertebral body | In the disc space between two vertebrae |
| Goal | Indirect decompression, designed to preserve motion at the disc | Interbody fusion |
| Fixation | Bilateral: screws and plate near side, staple far side, through a single lateral approach | Bilateral: screws and plate near side, staple far side, through a single lateral or oblique-lateral approach |
| FDA clearance | K241468 (November 2024) | K241487 (October 2024) |
Motion preservation
VBO®Vertiwedge®
Intraosseous system for Vertebral Body Osteotomy
Vertiwedge is placed within a single vertebral body to restore and support height for indirect decompression, without fusing across the disc. Bone screws and a lateral plate secure the near side of the vertebra, and its deployable staple secures the far side, through the same lateral approach. Vertiwedge is available in a wide range of sizes and lordotic and coronal angulations.
FDA cleared under K241468 (November 2024).
The Vertiwedge® Intraosseous System is indicated for use in the thoracolumbar spine (T1–L5) for partial replacement of a diseased or damaged vertebral body resected or excised to replace a portion and/or restore the height of a collapsed vertebral body for the treatment of previous trauma (i.e., fracture or tumor) or degenerative spine disease. See the Instructions for Use for full indications, contraindications, warnings, and precautions.
When fusion is the right choice
Interwedge® Standalone Lateral
Lateral lumbar interbody fusion system
Interwedge brings the same deployable staple to the disc space for patients who need an interbody fusion. Bone screws and a pivoting lateral plate secure the near side, and the deployable staple secures the far side through a single-position lateral or oblique-lateral approach. Interwedge is FDA cleared for standalone use when used as indicated with its accompanying bone screws.
- Deployable staple.
- Extends, rotates, and retracts to secure the far side; bone screws and the plate secure the near side.
- Pivoting lateral plate.
- Fixed to the implant, the lateral plate pivots to align with vertebral body anatomy.
- Porous lattice.
- 3D-printed titanium lattice.
- Sizing.
- Widths of 18, 22, and 26 mm; lengths of 40–60 mm; heights of 8–16 mm; lordosis of 3°, 10°, 15°, and 20°; coronal angulation of +5°, neutral, and −5°.
- Sterile packed.
- All implants are provided individually sterile packed.
FDA cleared under K241487 (October 2024).
The Interwedge® Standalone Lateral is a standalone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L1–S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six months of non-operative treatment, and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The device is used with the bone screws that accompany the implant. See the Instructions for Use for full indications, contraindications, warnings, and precautions.
Request product informationCoding and reimbursement
Coding support for both procedures.
VBO and Interwedge procedures are each reported using established Category I CPT® codes. Our coding and reimbursement team is available to help surgeons, practices, and hospitals with coding questions, documentation, and preauthorization.
Coding information is provided for reference only. Providers are responsible for code selection, and the existence of a code does not guarantee coverage or payment. CPT® is a registered trademark of the American Medical Association.
Questions about our technologies?
Our team can help with product, technical, or coding questions.
Talk to our teamRx only. Federal law restricts these devices to sale by or on the order of a physician. Refer to the Instructions for Use for each device for a complete list of indications, contraindications, warnings, and precautions.