Cleared Traditional

K140508 - ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS

K140508 is an FDA 510(k) clearance for ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- N..., 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 167-day FDA review.

K140508 · Zimmer, Inc. · Orthopedic device
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Aug 2014
Decision
167d
Days
Class 2
Risk

K140508 is an FDA 510(k) clearance for the ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND 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 August 14, 2014 after a review of 167 days - an extended review 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: 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

FDA 510(k) Submission Details - K140508

510(k) Number K140508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2014
Decision Date August 14, 2014
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 K140508.
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
K142135 · Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic · Aug 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · Wrightmedicaltechnologyinc · Aug 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · Arthrex, Inc. · Aug 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517 · Zimmer, Inc. · Aug 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734 · Zimmer, Inc. · Aug 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241 · Synthes USA Products, LLC · Aug 2014