Cleared Traditional

Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS (K143331) - FDA 510(k) Clearance

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

K143331 · Zimmer, Inc. · Orthopedic device
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Mar 2015
Decision
104d
Days
Class 2
Risk

K143331 is an FDA 510(k) clearance for the Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS. 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 March 4, 2015 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K143331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date March 04, 2015
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 K143331.
DARCO Locking Bone Plate System
K150520 · Wrightmedicaltechnologyinc · Apr 2015
Arthrex Distal Radius System
K143749 · Arthrex, Inc. · Apr 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · Synthes (Usa) · Mar 2015
Zimmer Periarticular Plating System
K150121 · Zimmer, Inc. · Feb 2015
Arthrex Fracture System
K143139 · Arthrex, Inc. · Jan 2015
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · Smith & Nephew, Inc. · Dec 2014