Cleared Traditional

K201072 - Ensemble CMC

K201072 is the FDA 510(k) clearance for Ensemble CMC by Ensemble Orthopedics, LLC. It is a Class 2 Orthopedic device (product code KYI) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

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.

Regulatory Peers - KYI Prosthesis, Wrist, Carpal Trapezium

All 9
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K201072.
Stablyx CMC Arthroplasty Implant System
K180744 · Skeletal Dynamics, LLC · Apr 2018
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
K061089 · Biopro, Inc. · Jun 2006
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
K052596 · Biopro, Inc. · Nov 2005
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc · Dec 2003
METALLIC SPHERICAL CMC IMPLANT
K960534 · Wrightmedicaltechnologyinc · Feb 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · Wrightmedicaltechnologyinc · Feb 1997