Cleared Traditional

DePuy Synthes Sterilization Container System (K181933) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181933 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · General Hospital
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May 2019
Decision
294d
Days
Class 2
Risk

K181933 is an FDA 510(k) clearance for the DePuy Synthes 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 / Depuy Orthopaedics, Inc. (West Chester, US). The FDA issued a Cleared decision on May 9, 2019 after a review of 294 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K181933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2018
Decision Date May 09, 2019
Days to Decision 294 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
165d slower than avg
Panel avg: 129d · This submission: 294d
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 139
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K181933.
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
K191475 · Nobel Biocare AB · Aug 2019
Aesculap® SterilContainer(TM) S2 System
K182414 · Aesculap, Inc. · Jul 2019
Sonopet iQ Sterilization Tray
K190667 · Paragon Medical · Jun 2019
Neodent Instruments Kits
K182865 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · May 2019
Stryker ChestShield Sterilization Tray System
K183701 · Paragon Medical · May 2019
TCAT (R) THA Instrument Tray Set
K180127 · THINK Surgical, Inc. · Mar 2019