Cleared Traditional

K170802 - TRAUMACEM V+ Injectable Bone Cement

K170802 is the FDA 510(k) clearance for TRAUMACEM V+ Injectable Bone Cement by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code LOD) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K170802 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
195d
Days
Class 2
Risk

K170802 is an FDA 510(k) clearance for the TRAUMACEM™ V+ Injectable Bone Cement. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on September 28, 2017 after a review of 195 days - an extended review 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: 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K170802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date September 28, 2017
Days to Decision 195 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
73d slower than avg
Panel avg: 122d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01473082 Completed Interventional

Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

251
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Hip Fractures; Closed Fracture of Hip
Study design Parallel
Eligibility All sexes · 75 Years+
Principal investigator Andreas Faeh
Sponsor AO Clinical Investigation and Publishing Documentation
Started 2012-02-01 → Primary completion 2015-12-01 → Completed 2016-01-01
Primary outcome
Mobility measured with the "timed up & go"-test during hospital stay.
Secondary outcome
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LOD Bone Cement

All 51
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K170802.
PALACOS MV
K182260 · Heraeus Medical GmbH · Sep 2018
OrthoSteady G Bone Cement
K173494 · G21, S.R.L. · Mar 2018
Biomet Bone Cement R
K172408 · Biomet, Inc. · Oct 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
COBALT MV BONE CEMENT
K091608 · Biomet Manufacturing Corp · Sep 2009