510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201072Substantially Equivalent

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

Ensemble Orthopedics, Inc, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201072 is the FDA 510(k) clearance record for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161, a class II device, cleared for Ensemble Orthopedics, LLC on under FDA product code KYI (Prosthesis, Wrist, Carpal Trapezium). FDA records list one 510(k) clearance for Ensemble Orthopedics, LLC. As of , FDA records show no recalls naming K201072.

Clearance record

Decision date
Received
(224 days to decision)
Product code
KYI Prosthesis, Wrist, Carpal Trapezium
Regulation
21 CFR 888.3770
Device class
Class II
Review panel
Orthopedic
Applicant
Ensemble Orthopedics, LLC 107 Redbud Trl., Suite 11, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYI

Trailing 12 months

FDA records hold no clearances under product code KYI in the trailing twelve months.

FDA records show no clearances under product code KYI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260