Cleared Traditional

K130720 - SYNTHES REUSABLE STERILIZATION CONTAINE...

K130720 is the FDA 510(k) clearance for SYNTHES REUSABLE STERILIZATION CONTAINE... by Synthes USA Products, LLC. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 514-day FDA review.

K130720 · Synthes USA Products, LLC · General Hospital
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Aug 2014
Decision
514d
Days
Class 2
Risk

K130720 is an FDA 510(k) clearance for the SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on August 14, 2014 after a review of 514 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Synthes USA Products, LLC devices

Submission Details

510(k) Number K130720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date August 14, 2014
Days to Decision 514 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
385d slower than avg
Panel avg: 129d · This submission: 514d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 150
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K130720.
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