510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K060412Substantially Equivalent

Active Unicompartmental Knee System

Australian Surgical Design & Manufacture, Annapolis MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060412 is the FDA 510(k) clearance record for ACTIVE UNICOMPARTMENTAL KNEE SYSTEM, a class II device, cleared for Australian Surgical Design & Manufacture on under FDA product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer). FDA records list one 510(k) clearance for Australian Surgical Design & Manufacture. As of , FDA records show no recalls naming K060412.

Clearance record

Decision date
Received
(90 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
Australian Surgical Design & Manufacture 2530 Riva Rd., Suite 308, Annapolis MD
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