Cleared Traditional

K062978 - U2 HIP STEM

K062978 is an FDA 510(k) clearance for U2 HIP STEM, manufactured by United Orthopedic Corp.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K062978 · United Orthopedic Corp. · Orthopedic device
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Jan 2007
Decision
109d
Days
Class 2
Risk

K062978 is an FDA 510(k) clearance for the U2 HIP STEM, TI PLASMA SPRAY. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by United Orthopedic Corp. (Hsinchu, TW). The FDA issued a Cleared decision on January 16, 2007 after a review of 109 days - within the typical 510(k) review window.

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 United Orthopedic Corp. devices

FDA 510(k) Submission Details - K062978

510(k) Number K062978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date January 16, 2007
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 66
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K062978.
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
EXCIA
K061699 · Aesculap, Inc. · Aug 2006
BETACONE HIP PROSTHESIS SYSTEM
K051826 · Waldemar Link GmbH & Co. KG · Nov 2005
U2 ACETABULAR COMPONENT
K050262 · United Orthopedic Corp. · Aug 2005