Cleared Traditional

K142836 - Zimmer Plates and Screws (ZPS)

K142836 is the FDA 510(k) clearance for Zimmer Plates and Screws (ZPS) by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K142836 · Zimmer, Inc. · Orthopedic device
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Nov 2014
Decision
43d
Days
Class 2
Risk

K142836 is an FDA 510(k) clearance for the Zimmer Plates and Screws (ZPS), Forte Screws. 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 November 12, 2014 after a review of 43 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 K142836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date November 12, 2014
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 918
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K142836.
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · Smith & Nephew, Inc. · Dec 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025 · Wrightmedicaltechnologyinc · Dec 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
K143066 · Zimmer, Inc. · Nov 2014
Zimmer Periarticular Plating System
K142579 · Zimmer, Inc. · Oct 2014
PRO-LINK WEDGE SYSTEM
K141905 · Life Spine · Sep 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · Synthes USA Products, LLC · Aug 2014