K241035 is an FDA 510(k) clearance for the PMT Posterior Cervical Stabilization System (PCSS). Classified as System, Facet Screw Spinal Device (product code MRW).
Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 25, 2024 after a review of 70 days - a notably fast clearance cycle.
This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.
View all Providence Medical Technology, Inc. devices
NCT04229017
Active not recruiting
Interventional
Industry-sponsored
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease
| Condition studied |
Degenerative Disc Disease |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Matt Jenkins |
| Sponsor |
Providence Medical Technology, Inc.
(industry)
|
Started 2020-03-18
→
Primary completion 2024-07-22
→
Completed 2025-12-01
Primary outcome
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
Secondary outcome
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
View full study on ClinicalTrials.gov