Cleared Traditional

K112907 - CONFIDENCE HIGH VISCOSITY SPINAL CEMENT

K112907 is the FDA 510(k) clearance for CONFIDENCE HIGH VISCOSITY SPINAL CEMENT by Medos International SARL. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K112907 · Medos International SARL · Orthopedic device
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Dec 2011
Decision
80d
Days
Class 2
Risk

K112907 is an FDA 510(k) clearance for the CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Medos International SARL (Raynham, US). The FDA issued a Cleared decision on December 22, 2011 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. 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 Medos International SARL devices

Submission Details

510(k) Number K112907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 22, 2011
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NDN Cement, Bone, Vertebroplasty

All 49
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