Cleared Traditional

K193546 - Distal Centralizers

K193546 is an FDA 510(k) clearance for Distal Centralizers, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K193546 · Biomet, Inc. · Orthopedic device
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Sep 2020
Decision
280d
Days
Class 2
Risk

K193546 is an FDA 510(k) clearance for the Distal Centralizers. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 25, 2020 after a review of 280 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K193546

510(k) Number K193546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date September 25, 2020
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 47
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K193546.
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
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Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K173499 · Stryker Orthopaedics · Mar 2018
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
K001984 · Stelkast Company · Sep 2000
THE TAPER-FIT TOTAL HIP SYSTEM
K992234 · Corin USA · Nov 1999
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · Exactech, Inc. · Aug 1996
NEXLOCK FEMORAL STEM
K955171 · Nexmed, Inc. · Feb 1996