Cleared Traditional

K142579 - Zimmer Periarticular Plating System

K142579 is an FDA 510(k) clearance for Zimmer Periarticular Plating System, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K142579 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
37d
Days
Class 2
Risk

K142579 is an FDA 510(k) clearance for the Zimmer Periarticular Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 22, 2014 after a review of 37 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K142579

510(k) Number K142579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date October 22, 2014
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K142579.
G3 Active Plate Large Fragment System
K142938 · Genesis Fracture Care, Inc. · Nov 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836 · Zimmer, Inc. · Nov 2014
Sternal Closure System
K142484 · Jace Medical, LLC · Oct 2014
PRO-LINK WEDGE SYSTEM
K141905 · Life Spine · Sep 2014
I.T.S. Hand Locking Plates System - HLS
K142418 · I.T.S. GmbH · Sep 2014
Flower Upper Extremity Plating Set
K142306 · Flower Orthopedics Corporation · Sep 2014