Cleared Traditional

K172408 - Biomet Bone Cement R

K172408 is the FDA 510(k) clearance for Biomet Bone Cement R by Biomet, Inc.. It is a Class 2 Orthopedic device (product code LOD) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K172408 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
57d
Days
Class 2
Risk

K172408 is an FDA 510(k) clearance for the Biomet 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 October 5, 2017 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K172408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2017
Decision Date October 05, 2017
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K172408.
G3A 40 Bone Cement
K181282 · G21, S.R.L. · Jan 2019
PALACOS MV
K182260 · Heraeus Medical GmbH · Sep 2018
OrthoSteady G Bone Cement
K173494 · G21, S.R.L. · Mar 2018
TRAUMACEM™ V+ Injectable Bone Cement
K170802 · Synthes USA Products, LLC · Sep 2017
Refobacin Bone Cement R
K171540 · Biomet, Inc. · Aug 2017
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · Biomet, Inc. · Oct 2009