Cleared Traditional

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (K201072) - FDA 510(k) Clearance

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

K201072 · Ensemble Orthopedics, LLC · Orthopedic device
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Dec 2020
Decision
224d
Days
Class 2
Risk

K201072 is an FDA 510(k) clearance for the Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Ensemble Orthopedics, LLC (Austin, US). The FDA issued a Cleared decision on December 2, 2020 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3770 - 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 Ensemble Orthopedics, LLC devices

Submission Details

510(k) Number K201072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2020
Decision Date December 02, 2020
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYI Prosthesis, Wrist, Carpal Trapezium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3770
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.