Cleared Traditional

K170089 - U-Motion II Acetabular System— Addition...

K170089 is the FDA 510(k) clearance for U-Motion II Acetabular System— Addition... by United Orthopedic Corporation. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K170089 · United Orthopedic Corporation · Orthopedic device
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Oct 2017
Decision
269d
Days
Class 2
Risk

K170089 is an FDA 510(k) clearance for the U-Motion II Acetabular System— Additional sizes. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on October 6, 2017 after a review of 269 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 K170089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2017
Decision Date October 06, 2017
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
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