Orthopedic & Spine
Alquest's experience in orthopedic therapies spans all manner of indications, therapies and technologies.
Spinal devices
Since 2001 Alquest has served well over a dozen orthopedic device-related clients, including seven manufacturers of spinal devices including injectables, fusion devices, fixation devices, and orthobiologics:
- Disc nucleus replacement
- Lumbar cage devices
- Annulus repair device
- Cervical and lumbar fixation devices
- Cervical cage device
- Biological fusion device
- Liquid based product
- Synthetic carriers of calcium product
- Combinations mixed with stem cell
- Spinal fusion
- Dynamic stabilization
- Artificial disc
- Pedicle screws
- Annulus repair
Other orthopedic devices
- Finger implants
- Orthotics and prosthetics (including microprocessor-controlled knee)
- Biocompatible polymers to resurface joint cartilage
- Small bone (wrist-hand-finger) implants
- Bone graft replacement material
- Bone morphogenetic protein-2 (BMP2) (dental indication)
- Replacement joints, total and partial (hip, knee, hand)
- Cartilage repair system
- Ultrasound to treat fractures
- Hyaluronic acid to treat arthritis in shoulder and knee
- Xenograft
- Scaffolds
- Injectors
- Cements
- Joint preservation
- Soft tissue repair matrix
- Endoscopy
- Autologous bone graft
- Allograph bone grafts (cadaveric)
Specific tasks Alquest has performed range from regulatory strategies, pre-IDE meetings, Quality System implementation, design controls, supplier audits, management reviews, site screening/qualification, site initiation, training, statistical sample size calculation, data management, IRB approvals, site contracting, core lab qualification, clinical monitoring, regulatory submissions [510(k), PMA, HDE, HUD, BLA, as well as supplements], site closeout, final clinical report, BIMO inspection preparation, FDA panel preparation, FDA advisory panel participation, to post-market study support, and more.