Cleared Traditional

K141235 - PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS

K141235 is an FDA 510(k) clearance for PROFEMUR RENAISSANCE CLASSIC LONG NECK ..., manufactured by Microport Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K141235 · Microport Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
122d
Days
Class 2
Risk

K141235 is an FDA 510(k) clearance for the PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on September 12, 2014 after a review of 122 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 Microport Orthopedics, Inc. devices

FDA 510(k) Submission Details - K141235

510(k) Number K141235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2014
Decision Date September 12, 2014
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 509
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K141235.
Klassic HD Hip System
K143407 · Total Joint Othopedics, Inc. · Dec 2014
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
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821 · Exactech, Inc. · Aug 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · Biomet, Inc. · Aug 2014
MINIMA S SYSTEM
K141327 · Lima Corporate S.P.A. · Aug 2014