Cleared Traditional

K142675 - CI../..X liner for NOVAE Dual Mobility ...

K142675 is an FDA 510(k) clearance for CI../..X liner for NOVAE Dual Mobility ..., manufactured by Serf. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K142675 · Serf · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
118d
Days
Class 2
Risk

K142675 is an FDA 510(k) clearance for the CI../..X liner for NOVAE Dual Mobility Acetabular Cup. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Serf (Decines, FR). The FDA issued a Cleared decision on January 15, 2015 after a review of 118 days - within the typical 510(k) review window.

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 Serf devices

FDA 510(k) Submission Details - K142675

510(k) Number K142675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date January 15, 2015
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 455
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K142675.
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096 · Smith & Nephew, Inc. · Mar 2015
Excia Total Hip System
K150062 · Aesculap Implant Systems, LLC · Feb 2015
MasterSL femoral stem
K143509 · Lima Corporate S.P.A. · Jan 2015
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
K141377 · Merete Medical GmbH · Nov 2014
LINK MP RECONSTRUCTION PROSTHESIS
K142187 · Waldemar Link GmbH & Co. KG · Nov 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235 · Microport Orthopedics, Inc. · Sep 2014