Cleared Traditional

UNITED U2 BIPOLAR IMPLANT (K101670) - FDA 510(k) Clearance

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

K101670 · United Orthopedic Corp. · Orthopedic device
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Oct 2010
Decision
116d
Days
Class 2
Risk

K101670 is an FDA 510(k) clearance for the UNITED U2 BIPOLAR IMPLANT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by United Orthopedic Corp. (Hsinchu, TW). The FDA issued a Cleared decision on October 8, 2010 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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

Submission Details

510(k) Number K101670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2010
Decision Date October 08, 2010
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 47
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K101670.
SurgTech Bipolar Head System
K173455 · Surgtech, Inc. · Jun 2018
ELEOS™ Bipolar Acetabular System
K180130 · Onkos Surgical, Inc. · Feb 2018
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · Signature Orthopaedics Pty, Ltd. · Jan 2018
GLADIATOR BIPOLAR SYSTEM
K062693 · Wrightmedicaltechnologyinc · Sep 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · Aesculap, Inc. · May 2006
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
K052990 · Biomet, Inc. · Dec 2005