Cleared Traditional

K163577 - Ecofit Hip System

K163577 is the FDA 510(k) clearance for Ecofit Hip System by Implantcast GmbH. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K163577 · Implantcast GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
279d
Days
Class 2
Risk

K163577 is an FDA 510(k) clearance for the Ecofit® Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on September 25, 2017 after a review of 279 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 K163577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date September 25, 2017
Days to Decision 279 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 122d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 420
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K163577.
M-Vizion Femoral Revision System
K170690 · Medacta International S.A. · Nov 2017
C2 femoral stem
K170473 · Lima Corporate S.P.A. · Nov 2017
U-Motion II Acetabular System— Additional sizes
K170089 · United Orthopedic Corporation · Oct 2017
PROCOTYL® PRIME E-CLASS™ XLPE Liner
K171181 · Microport Orthopedics, Inc. · Aug 2017
Locking Cage, Full XPE Cup
K163441 · United Orthopedic Corporation · Aug 2017
MiniMAX
K170845 · Medacta International S.A. · Aug 2017