Cleared Traditional

K120595 - UNISYN PLUS HIP STEM

K120595 is an FDA 510(k) clearance for UNISYN PLUS HIP STEM, manufactured by Consensus Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K120595 · Consensus Orthopedics, Inc. · Orthopedic device
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Oct 2012
Decision
227d
Days
Class 2
Risk

K120595 is an FDA 510(k) clearance for the UNISYN PLUS HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Consensus Orthopedics, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on October 12, 2012 after a review of 227 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Consensus Orthopedics, Inc. devices

FDA 510(k) Submission Details - K120595

510(k) Number K120595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date October 12, 2012
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 67
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K120595.
TRINITY ACETABULAR SYSTEM
K103518 · Corin USA · Mar 2011
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · Exactech, Inc. · Apr 2009
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
K082146 · Aesculap Implant Systems, Inc. · Sep 2008
U2 HIP STEM, TI PLASMA SPRAY
K062978 · United Orthopedic Corp. · Jan 2007
EXCIA
K061699 · Aesculap, Inc. · Aug 2006
BETACONE HIP PROSTHESIS SYSTEM
K051826 · Waldemar Link GmbH & Co. KG · Nov 2005