The FDA “cleared” 284 devices in August 2013 through the 510(k) program. Of those, 45 were orthopedic or spine related.
FDA Has Most August “Clearances” in Years
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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.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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