Cleared Traditional

K123550 - UTF STEM

K123550 is the FDA 510(k) clearance for UTF STEM by United Orthopedic Corporation. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K123550 · United Orthopedic Corporation · Orthopedic device
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May 2013
Decision
163d
Days
Class 2
Risk

K123550 is an FDA 510(k) clearance for the UTF STEM, REDUCED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on May 1, 2013 after a review of 163 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Corporation devices

Submission Details

510(k) Number K123550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date May 01, 2013
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K123550.
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207 · United Orthopedic Corporation · Aug 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · Encore Medical, L.P. · Jun 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · United Orthopedic Corporation · Jun 2013
ARCOS TROCHANTER BUTTON
K130063 · Biomet, Inc. · Apr 2013
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
K121297 · Signature Orthopaedics Pty, Ltd. · Dec 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898 · Lima Corporate S.P.A. · Dec 2012