The FDA “cleared” 284 devices in August 2013 through the 510(k) program. Of those, 45 were orthopedic or spine related.
During the same August period in 2010, 2011 and 2012, the agency cleared 241, 271 and 257 devices, respectively. Clearances are for products that have shown to be “Substantially Equivalent” to previously approved products.
The list of companies receiving recent clearances included familiar names:
- Biomet
- DePuy
- Medtronic
- Orthofix
- NuVasive
- Arthrocare
- Zimmer
- Aesculap
- Globus
- Spineguard
- Spine Wave
- Centinel Spine
- X-Spine
- Spinal USA
Other less well-known names included:
- Ascension Orthopedics
- Osseus Fusion
- Captiva Spine
- Iconacy Orthopedic Implants
- Core-Nexus
- FX Solutions
- Southern Spine
- Orthohelix Surgical Designs
- Tissue Regeneration Systems
- Accel Spine
- Ortho Development
- Medacta International
- Flower Orthopedics
- Neurostructures
- Medyssey
- Ingen Orthopedics
- Next Orthosurgical
- Neosteo
- Rotation Medical
- United Orthopedic
Cleared devices ranged from personalized care systems, fixation devices, interbody systems, nerve detectors, hip and shoulder systems, coblation wands, navigation instruments, bone fillers to bone staplers.
To see the entire list of all cleared devices, click here.
