Cleared Traditional

DePuy Synthes Trauma Orthopedic Plates and Screws (K180310) - FDA 510(k) Clearance

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

K180310 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
269d
Days
Class 2
Risk

K180310 is an FDA 510(k) clearance for the DePuy Synthes Trauma Orthopedic Plates and Screws. 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 November 1, 2018 after a review of 269 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic 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 K180310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2018
Decision Date November 01, 2018
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 698
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K180310.
ARIX Sternal System
K181806 · Jeil Medical Corporation · Nov 2018
AdvantageRib Anterior System
K182179 · Sig Medical Corp. · Nov 2018
Stratum™ Foot Plating System
K182201 · Nextremity Solutions, Inc. · Nov 2018
Medline Unite Mini Plates and Screws
K181820 · Medline Industries, Inc. · Nov 2018
AOS Calcaneal Plating System
K182466 · Advanced Orthopaedic Solutions · Oct 2018
ANTHEM Fracture System
K180554 · Globus Medical, Inc. · Oct 2018