Cleared Special

ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) (K083654) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083654 · Zimmer, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
78d
Days
Class 2
Risk

K083654 is an FDA 510(k) clearance for the ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM T.... 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 February 26, 2009 after a review of 78 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K083654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2008
Decision Date February 26, 2009
Days to Decision 78 days
Submission Type Special
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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

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 K083654.
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
K083843 · DePuy Orthopaedics, Inc. · Mar 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694 · Synthes (Usa) · Mar 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573 · Synthes (Usa) · Mar 2009
ANATOMIC LOCKING PLATING SYSTEM
K082300 · DePuy Orthopaedics, Inc. · Feb 2009
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025 · Synthes (Usa) · Jan 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · Smith & Nephew, Inc. · Jan 2009