Cleared Traditional

K190750 - DePuy Synthes Plates and Screws Portfolio

K190750 is the FDA 510(k) clearance for DePuy Synthes Plates and Screws Portfolio by DePuy Synthes. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K190750 · DePuy Synthes · Orthopedic device
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Jun 2019
Decision
88d
Days
Class 2
Risk

K190750 is an FDA 510(k) clearance for the DePuy Synthes Plates and Screws Portfolio. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by DePuy Synthes (West Chester, US). The FDA issued a Cleared decision on June 21, 2019 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DePuy Synthes devices

Submission Details

510(k) Number K190750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2019
Decision Date June 21, 2019
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K190750.
CoLink® Mini Plating System
K191535 · In2bones USA, LLC · Jul 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
K190963 · Synthes USA Products, LLC · Jul 2019
ORTHOLOC™ SPS Shoulder Plating System
K191711 · Tornier, Inc. · Jul 2019
LOQTEQ VA Foot Plates 2.5
K182785 · Aap Implantate AG · Jun 2019
Arzzt Distal Radius and Ulna System
K182650 · Truemed Group, LLC · Jun 2019
RIVAL View Plating Systems and Reduce Fracture Plating Systems
K190388 · Orthofix Srl · Jun 2019