One of our clients recently inquired about new products from Stryker, Medtronics, Biomet, and DePuy Synthes that are being used in spinal surgeries. Our search of PubMed, FDA databases, and the Internet showed that these manufacturers had multiple new devices that entered the market in 2014. Here is a list of some of the spinal implants and instrumentation that were reviewed by the FDA over the past year.
- AERO-AL Lumber Cage System: Intended to stabilize the lumbar spinal segments to promote fusion in order to restrict motion and decrease pain.
- AVS AS Peek Spacer: Intended to stabilize cervical spine segments to promote fusion in order to restrict motion and decrease pain using bone graft.
- XIA 3 or 4.5 Spinal System: Intended for use in patients younger than 10 years of age who require surgery for severe, progressive, life-threatening early onset spinal deformities associated with thoracic insufficiency.
From DePuy Synthes:
- SYNAPSE System: Enables the surgeon to build an implant system to provide spinal fixation to allow for stabilization of the cervical spine and occipito-cervical junction in skeletally mature patients as an adjunct to fusion.
- Lateral SYNFIX: A stand-alone lateral lumbar interbody fusion device indicated for degenerative disc disease at one or two contiguous levels from L2 – L5.
- Synthes OC FUSION System: Intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction.
- Biomet Probes/Guidewires and Dilators: Intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
- PerFuse Percutaneous Decompression System: Intended to be used for the delivery of allograft, autograft, and synthetic bone graft material to an orthopedic surgical site.
- Polaris Spinal System: A noncervical spinal fixation for immobilization and stabilization as an adjunct to pedicle screw fixation system, a posterior hook, and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system with allograft and/or autograft.
- BioMet Intervertebral Body/VBR Fusion System: Intended for use as a cervical or lumbar intervertebral fusion device or as a vertebral body replacement.
- MaxAn Anterior Cervical Plate System: Intended for spinal vertebral body fixation.
- CD Horizon Spinal System: Spinal intervertebral body fixation orthosis intended for posterior noncervical fixation as an adjunct to fusion with or without SEXTANT instrumentation.
- PRESTIGE LP Surgical Disc: Intended for use in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy.
- DIVERGENCE Anterior Cervical Fusion System: Allows simultaneous insertion of plate and interbody cage using common instruments and a single surgical technique.
- KYPHON Express II Balloon Kyphoplasty Platform: For the treatment of vertebral compression fractures.
- PEEK Interbody Fusion Devices: Three different devices intended for interbody fusion procedures.