Cleared Traditional

K160553 - DePuy Synthes 4.0 mm and 5.0 mm Locking...

K160553 is an FDA 510(k) clearance for DePuy Synthes 4.0 mm and 5.0 mm Locking..., manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 487-day FDA review.

K160553 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
487d
Days
Class 2
Risk

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.

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

FDA 510(k) Submission Details - K160553

510(k) Number K160553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date June 30, 2017
Days to Decision 487 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 122d · This submission: 487d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1006
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