Cleared Traditional

K101670 - UNITED U2 BIPOLAR IMPLANT

K101670 is an FDA 510(k) clearance for UNITED U2 BIPOLAR IMPLANT, manufactured by United Orthopedic Corp.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

FDA 510(k) Submission Details - K101670

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
Combination Product No
PCCP Authorized No
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.

KWY Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K101670.
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