Cleared Traditional

K171540 - Refobacin Bone Cement R

K171540 is an FDA 510(k) clearance for Refobacin Bone Cement R, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K171540 · Biomet, Inc. · Orthopedic device
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Aug 2017
Decision
96d
Days
Class 2
Risk

K171540 is an FDA 510(k) clearance for the Refobacin Bone Cement R. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 30, 2017 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 - K171540

510(k) Number K171540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date August 30, 2017
Days to Decision 96 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

Product Code LOD Bone Cement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - LOD Bone Cement

All 63
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K171540.
OrthoSteady G Bone Cement
K173494 · G21, S.R.L. · Mar 2018
Biomet Bone Cement R
K172408 · Biomet, Inc. · Oct 2017
TRAUMACEM™ V+ Injectable Bone Cement
K170802 · Synthes USA Products, LLC · Sep 2017
OSTEOPAL plus
K153737 · Heraeus Medical GmbH · Apr 2016
V-STEADY, V-FAST
K150408 · G21, S.R.L. · Dec 2015
PALACOS R pro
K150119 · Heraeus Medical GmbH · Jun 2015