Cleared Traditional

ZIMMER PERIARTICULAR LOCKING SYSTEM (K141734) - FDA 510(k) Clearance

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

K141734 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
47d
Days
Class 2
Risk

K141734 is an FDA 510(k) clearance for the ZIMMER PERIARTICULAR LOCKING 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 August 13, 2014 after a review of 47 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

Submission Details

510(k) Number K141734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2014
Decision Date August 13, 2014
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
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 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141734.
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · Arthrex, Inc. · Aug 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508 · Zimmer, Inc. · Aug 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517 · Zimmer, Inc. · Aug 2014
BIOFOAM BONE WEDGE
K140531 · Wrightmedicaltechnologyinc · Jul 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417 · Wrightmedicaltechnologyinc · Jul 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · Arthrex, Inc. · Jul 2014