Cleared Traditional

K191414 - EXETER Centralizer

K191414 is the FDA 510(k) clearance for EXETER Centralizer by Stryker Orthopaedics. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K191414 · Stryker Orthopaedics · Orthopedic device
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Aug 2019
Decision
92d
Days
Class 2
Risk

K191414 is an FDA 510(k) clearance for the EXETER Centralizer, EXETER 2.5mm Plug. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on August 28, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Stryker Orthopaedics devices

Submission Details

510(k) Number K191414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2019
Decision Date August 28, 2019
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 438
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K191414.
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
K200823 · Zimmer, Inc. · Jul 2020
CPT Hip System
K191735 · Zimmer, Inc. · Mar 2020
Conformity stem, cemented
K191056 · United Orthopedic Corporation · Jan 2020
Cemented TSI Hip Stem
K181340 · Signature Orthopaedics Pty, Ltd. · Feb 2019
Libertas Hip Replacement System
K180973 · Maxx Orthopedics, Inc. · Sep 2018
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016