Cleared Traditional

U2 Hip Stem, Ti Porous Coated, Matrix (K151316) - FDA 510(k) Clearance

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

K151316 · United Orthopedic Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
87d
Days
Class 2
Risk

K151316 is an FDA 510(k) clearance for the U2 Hip Stem, Ti Porous Coated, Matrix. 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 August 13, 2015 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United Orthopedic Corporation devices

Submission Details

510(k) Number K151316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date August 13, 2015
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K151316.
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · Smith & Nephew, Inc. · Nov 2015
Arcos One-piece Femoral Revision System
K151603 · Biomet, Inc. · Oct 2015
Exactech® Novation® Crown Cup®
K141960 · Exactech, Inc. · Sep 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
K151448 · Zimmer, Inc. · Aug 2015
G7 Dual Mobility System
K150522 · Biomet, Inc. · May 2015
Echo Bi-Metric Microplasty Line Extension
K150503 · Biomet, Inc. · Mar 2015