Cleared Traditional

K172251 - UTS Stem

K172251 is the FDA 510(k) clearance for UTS Stem by United Orthopedic Corporation. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K172251 · United Orthopedic Corporation · Orthopedic device
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Oct 2017
Decision
90d
Days
Class 2
Risk

K172251 is an FDA 510(k) clearance for the UTS Stem. 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 October 24, 2017 after a review of 90 days - within the typical 510(k) review window.

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 K172251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2017
Decision Date October 24, 2017
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K172251.
Bone Screws 6.5mm
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K171934 · Smith & Nephew, Inc. · Nov 2017
Smith & Nephew, Inc. REDAPT Augments
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Bencox Mirabo Cup System
K172806 · Corentec Co., Ltd. · Oct 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · Smith & Nephew, Inc. · Oct 2017
U2 Femoral Head
K162957 · United Orthopedic Corporation · Jul 2017