Cleared Traditional

K191414 - EXETER Centralizer, EXETER 2.5mm Plug

K191414 is an FDA 510(k) clearance for EXETER Centralizer, manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K191414

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.

JDI Device Classification - Class 2, Special Controls

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 514
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
MALUC™ Total Hip Arthroplasty System
K162125 · Surgtech, Inc. · May 2017