Cleared Traditional

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) (K211051) - FDA 510(k) Clearance

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

K211051 · DePuy Synthes · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
55d
Days
Class 2
Risk

K211051 is an FDA 510(k) clearance for the DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment.... 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 2, 2021 after a review of 55 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 K211051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2021
Decision Date June 02, 2021
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K211051.
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
K200575 · Truemed Group, LLC · Jul 2021
Smith & Nephew Plates and Screws
K210837 · Smith & Nephew, Inc. · Jun 2021
Valkyrie Thoracic Fixation System
K211695 · Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · Jun 2021
DRPx Locking Distal Radius Plate System
K202971 · Orthopaedic Implant Company · May 2021
JACE Medical Thoracic Plating System
K210290 · Jace Medical, LLC · Apr 2021
SOLE Medial Column Fusion Plate
K210157 · Orthofix Srl · Apr 2021