Cleared Traditional

K181778 - MUTARS Proximal Femur Replacement System

K181778 is the FDA 510(k) clearance for MUTARS Proximal Femur Replacement System by Implantcast GmbH. It is a Class 2 Orthopedic device (product code MEH) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K181778 · Implantcast GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
265d
Days
Class 2
Risk

K181778 is an FDA 510(k) clearance for the MUTARS Proximal Femur Replacement System. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on March 25, 2019 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Implantcast GmbH devices

Submission Details

510(k) Number K181778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2018
Decision Date March 25, 2019
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 Consultant

Musculoskeletal Clinical Regulatory Advisers, LLC
Dave McGurl

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 126
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K181778.
MUTARS Cemented Femoral Stems
K200045 · Implantcast GmbH · Oct 2020
World Hip Stem, World Cup, World Liner
K201278 · Signature Orthopaedics Pty, Ltd. · Sep 2020
Summit DuoFix HA Coating
K193398 · DePuy Orthopaedics, Inc. · Feb 2020
Corin TriFit CF Hip Stem
K173880 · Corin U.S.A. Limited · Apr 2018
LINK® BiMobile(TM) Dual Mobility System
K171273 · Waldemar Link GmbH & Co. KG · Jan 2018
REDAPT Sleeved Monolithic Revision Stems
K162303 · Smith & Nephew, Inc. · May 2017