Cleared Traditional

K080879 - ACTIVATM PRODUCT GROUP INCLUDING BIOABS...

K080879 is an FDA 510(k) clearance for ACTIVATM PRODUCT GROUP INCLUDING BIOABS..., manufactured by Bioretec, Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K080879 · Bioretec, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
85d
Days
Class 2
Risk

K080879 is an FDA 510(k) clearance for the ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTI.... Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Cleared decision on June 24, 2008 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Bioretec, Ltd. devices

FDA 510(k) Submission Details - K080879

510(k) Number K080879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date June 24, 2008
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 111
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