Vy Spine has launched sterile-packed, disposable ClariVy™ instrument kits for use with its sterile-packed ClariVy™ OsteoVy™ PEKK implants. The kits can be used in both standard and stand-alone procedures. With the launch, the Tallahassee, Florida company now supplies both the implant and the instruments needed to place it in sterile packaging. Hospitals and surgery centers receive what they need for the case ready to open, with no reusable tray to clean and sterilize afterward.
The kits are designed around the ClariVy OsteoVy PEKK Cervical IBF, which received FDA 510(k) clearance in November 2023. The device is cleared for intervertebral body fusion at one level of the cervical spine, from C3 to T1, in patients with degenerative disc disease.Because the same kit supports standard and stand-alone techniques, facilities don’t have to stock separate instrument sets for each approach. The surgeon can choose the construct based on the patient and still work from one kit.
Disposable instruments have been gaining ground in spine for several years, especially in ambulatory surgery centers. Reusable sets usually travel between distributors and facilities, and they have to be cleaned, inspected and sterilized after every case. That cycle takes staff time and money, and a missing or improperly processed instrument can delay a procedure. Single-use kits move that work back to the manufacturer and give the facility a fixed cost per case.
Cervical fusion is also one of the procedures moving most steadily into the outpatient setting, where sterile processing capacity is often limited and room turnover matters. A sterile implant paired with sterile instruments fits well in that environment.
On the implant side, the system is built on OsteoVy PEKK, Vy Spine’s interbody platform. The ClariVy device is made from OXPEKK, a polyetherketoneketone material from Oxford Performance Materials, 3D printed with OPM’s OsteoFab process and combined with Vy Spine’s proprietary OsteoVy lattice structure.
Vy Spine has positioned PEKK as an alternative to PEEK, still the most widely used polymer for interbody cages. The company points to data showing bone ingrowth on PEKK, no radiographic interference, no fibrotic tissue membrane formation, increasing bony apposition over time and higher push-out strength than standard PEEK. Because PEKK is hydrophilic, the OsteoVy lattice also wicks fluid in addition to supporting bony integration.
When the cervical implant was cleared, Bret Berry, Vy Spine’s President of Product Development, said it would be the first of a long line of company implants using its OsteoVy PEKK designs. Since then, Vy Spine has received FDA clearance for the 3D printed LumiVy OsteoVy PEKK Lumbar IBF and for the VyBrate VBR System.
The ClariVy kits take the sterile-packed approach one step further, from the implant to the instruments used to place it. For surgeons and facilities already using ClariVy OsteoVy PEKK implants, the kits mean the full procedure can now be supplied sterile from a single source. For information on availability and ordering, contact Vy Spine.Website: www.vyspine.com
About Vy Spine
Vy Spine™, LLC was created through active internal development and the licensing of various proven technologies using innovative materials and designs. Our comprehensive line of core spine products and our newly developed specialty products allow us to meet the needs of both health care providers and surgeons. We continuously strive to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care.