K160553 - DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (FDA 510(k) Clearance)

K160553 is an FDA 510(k) clearance for the DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthe.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (West Chester, US). The FDA issued a Cleared decision on June 30, 2017 after a review of 487 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Orthopedic submissions.

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