Cleared Traditional

K122635 - TORNIER INSITE FT BIOCOMPOSITE SUTURE A...

K122635 is the FDA 510(k) clearance for TORNIER INSITE FT BIOCOMPOSITE SUTURE A... by Tornier, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K122635 · Tornier, Inc. · Orthopedic device
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May 2013
Decision
257d
Days
Class 2
Risk

K122635 is an FDA 510(k) clearance for the TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on May 13, 2013 after a review of 257 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tornier, Inc. devices

Submission Details

510(k) Number K122635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2012
Decision Date May 13, 2013
Days to Decision 257 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
135d slower than avg
Panel avg: 122d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

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