Cleared Traditional

UNISYN PLUS HIP STEM (K120595) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 80
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K120595.
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · Exactech, Inc. · Apr 2009
EXCIA
K061699 · Aesculap, Inc. · Aug 2006
EXCIA TOTAL HIP SYSTEM
K042344 · Aesculap, Inc. · Mar 2005
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · Howmedica Osteonics Corp. · Mar 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · DePuy Orthopaedics, Inc. · Feb 2003
PRO-FEMUR R
K003016 · Wrightmedicaltechnologyinc · Dec 2000