Cleared Traditional

K002755 - NON-ABSORBING STERNATOMY MONOFILAMENT S...

K002755 is an FDA 510(k) clearance for NON-ABSORBING STERNATOMY MONOFILAMENT S..., manufactured by T. Korossurgical Instruments Corp.. The device is a Class 2 Orthopedic device with product code LRN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002755 · T. Korossurgical Instruments Corp. · Orthopedic device
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Dec 2000
Decision
90d
Days
Class 2
Risk

K002755 is an FDA 510(k) clearance for the NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE. Classified as Wire, Surgical (product code LRN), Class II - Special Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 90 days - within the typical 510(k) review window.

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 T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K002755

510(k) Number K002755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date December 04, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRN Device Classification - Class 2, Special Controls

Product Code LRN Wire, Surgical
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.