510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081293Substantially Equivalent

Univation Unicondylar Knee System

Aesculap Inc, Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081293 is the FDA 510(k) clearance record for UNIVATION UNICONDYLAR KNEE SYSTEM, a class II device, cleared for Aesculap Implant Systems, Inc. on under FDA product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 269 510(k) clearances for AESCULAP, INC., from to . As of , FDA records show 8 recalls naming K081293.

Clearance record

Decision date
Received
(138 days to decision)
Product code
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3530
Device class
Class II
Review panel
Orthopedic
Applicant
Aesculap Implant Systems, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRY

Trailing 12 months

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

FDA records show no clearances under product code HRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRY, 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