Cleared Traditional

K020872 - SYNTHES 3.5 MM BROAD LC-DCP PLATES

K020872 is the FDA 510(k) clearance for SYNTHES 3.5 MM BROAD LC-DCP PLATES by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K020872 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
86d
Days
Class 2
Risk

K020872 is an FDA 510(k) clearance for the SYNTHES 3.5 MM BROAD LC-DCP PLATES. 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) (Paoli, US). The FDA issued a Cleared decision on June 12, 2002 after a review of 86 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 Synthes (Usa) devices

Submission Details

510(k) Number K020872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date June 12, 2002
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K020872.
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · Synthes (Usa) · Jul 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · Synthes (Usa) · Jul 2002
WRIST FUSION PLATE
K021321 · Acu Med, Inc. · Jul 2002
SYNTHES CALCANEAL PLATE
K020401 · Synthes (Usa) · May 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · Biomet, Inc. · Apr 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
K020221 · Biomet Orthopedics, Inc. · Apr 2002