510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K161060Substantially Equivalent

Arthrex iBalance UKA System Vitamin E Tibial Bearing

Arthrex GmbH, Naples FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161060 is the FDA 510(k) clearance record for Arthrex iBalance UKA System Vitamin E Tibial Bearing, a class II device, cleared for Arthrex, Inc. on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K161060.

Clearance record

Decision date
Received
(244 days to decision)
Product code
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3520
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrex, Inc. 1370 Creekside Blvd., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSX

Trailing 12 months
2 clearances under product code HSX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260